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 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 2-4 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 2 introduces “further comprising a delivery device”. It is unclear if the delivery device is the same delivery device as recited in claim 1. As understood by the Examiner in light of the specification, there is only one delivery device, which has already been positively introduced and required by claim 1. For examination purposes and as best understood by the Examiner in light of the specification, the Examiner will interpret claim 2 as - - The suture device of claim 1, wherein the delivery device extends within the suture channel, the delivery device operable to deploy an anchor component of the plurality of anchor components. - -.
Claim(s) 3-4 are rejected as being dependent on, and failing to cure the deficiencies of, their rejected respective parent claims.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-5, 7-10, 12-15, 17-20 are is/are rejected under 35 U.S.C. 103 as being unpatentable over Nakao (US 2005/0234512) in view of Vargas (US 2015/0250470).
Claim 1. Nakao discloses a suture device ([0016]), comprising:
an elongate member (endoscope) having a proximal end (end closer to user) and a distal end (end furthest from user), and defining a working channel and a suture channel ([0044], flexible endoscope may include one or more channels; in the instance there are at least two channels, one is considered the working channel and the other is considered a suture channel), wherein the suture channel is a lumen extending longitudinally throughout the elongate member ([0045]; as tubular body 12 is passed through the endoscope, the suture channel therefore is a lumen that extends longitudinally throughout the elongate member) ([0043]-[0045])
a suture (11) extending through the suture channel ([0045], the suture is within delivery device 12, wherein the delivery device is within the suture channel (the channel in the endoscope containing this instrument)); and
a plurality of anchor components (10) coupled to the suture such that each of the plurality of anchor components is configured to be disposed along a suture axis within a delivery device (12) prior to deployment (Figs. 1, 2, 8; [0045], [0062]);
wherein:
the suture and the plurality of anchor components are deployable from the elongate member for engagement with a target tissue (40) (Figs. 8, 9; [0045], [0066], [0067]); and
at least one anchor component of the plurality of anchor components comprises a plurality of legs (16) (Figs. 6, 7), and an attachment device (34) coupled to the plurality of legs and including a deformable loop surrounding the suture ([0061]; “the body 34 might be provided with an opening through which line element 11 may traverse”; by having an opening provided in the oval shape body 34, a loop is thereby formed from the body 34 (not shown). The body 45 may be formed of similar materials as legs 16, such as an elastic spring bias material or shape memory alloy as disclosed in [0054]. Therefore, since the body 34, in the form of a loop with an opening therethrough, is formed of an elastic material, it is thereby a deformable loop).
Nakao discloses the attachment device (34) is a crimping mechanism for holding the plurality of legs together ([0059], [0061], [0063]) but fails to disclose it is deformable to secure the anchor component to the suture. However, in the same field of endeavor of an endoscopic suturing instrument, Vargas teaches an elongate member (endoscope) ([0011], [0015]) for delivering a suture and plurality of anchor components (Fig. 13), wherein a crimping mechanism in the form of a loop or bridge (161) (akin to the loop of attachment device 34 in Nakao) is provided and a suture is traversed therethrough (akin to the suture 11 traversed through the body 34 of Nakao). The crimping mechanism (161) is deformable to secure the anchor component (160) to the suture (115) (Fig. 1A; [0085]). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify Nakao such that the attachment device (crimping mechanism 34) is deformable to secure the anchor component to the suture as taught by Vargas to selectively lock the suture in the desired configuration and tension to approximate and repair tissue ([0004], [0005], [0080]).
Claim 2. The combination discloses the invention substantially as claimed above, wherein Nakao further discloses comprising the delivery device (12) extending within the suture channel, the delivery device operable to deploy an anchor component of the plurality of anchor components ([0045], [0062]).
Claim 3. The combination discloses the invention substantially as claimed above, wherein the delivery device (12) of Nakao is capable of being retractable towards the proximal end of the elongate member to deploy the anchor component of the plurality of anchor components. Applicant is reminded claim 3 is directed to an apparatus claim and not a method of use. Therefore, the structure of the prior art only needs to be capable of performing such a function. The device of Nakao uses a pusher (14) to deploy the plurality of anchor components. Therefore, if the pusher is held stationary, while the delivery device is retracted, the plurality of anchor components would be deployed and pushed out by the pusher ([0045]).
Claim 4. The combination discloses the invention substantially as claimed above, wherein it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention that the delivery device (12) of Nakao extends beyond the distal end of the elongate member (endoscope) as Nakao discloses the delivery device is passed through the endoscope and terminates in a sharp hollow tip (13) ([0045]). Therefore, the sharp hollow tip that is passed through must extend beyond the distal end of the endoscope to thereby use the tip (otherwise the tip would remain retracted within the endoscope).
Claim 5. The combination discloses the invention substantially as claimed above, wherein Nakao further discloses the plurality of legs are biasable from a first, collapsed configuration (Fig. 7; [0047]) to a second, expanded configuration upon deployment (Fig. 6; [0051]-[0053]).
Claim 7. Nakao discloses an endoscopic medical device ([0016]), comprising:
an elongate member (endoscope) having a proximal end (end closer to user) and a distal end (end furthest from user), and defining a working channel and a suture channel ([0044], flexible endoscope may include one or more channels; in the instance there are at least two channels, one is considered the working channel and the other is considered a suture channel), wherein the suture channel is a lumen extending longitudinally throughout the elongate member ([0045]; as tubular body 12 is passed through the endoscope, the suture channel therefore is a lumen that extends longitudinally throughout the elongate member) ([0043]-[0045])
a delivery device (12) extending through the suture channel (Figs. 1-2; [0045]);
a suture (11) extending through the delivery device (Figs. 1-2; [0045]); and
a plurality of anchor components (10) coupled to the suture (Figs. 1-2, 6-9) ([0045]);
wherein:
the suture and the plurality of anchor components are deployable from the delivery device for engagement with a target tissue (40) (Figs. 8, 9; [0045], [0066], [0067]; and
at least one anchor component of the plurality of anchor components comprises a plurality of legs (16) (Figs. 6, 7), and an attachment device (34) coupled to the plurality of legs and including a deformable loop surrounding the suture ([0061]; “the body 34 might be provided with an opening through which line element 11 may traverse”; by having an opening provided in the oval shape body 34, a loop is thereby formed from the body 34 (not shown). The body 45 may be formed of similar materials as legs 16, such as an elastic spring bias material or shape memory alloy as disclosed in [0054]. Therefore, since the body 34, in the form of a loop with an opening therethrough, is formed of an elastic material, it is thereby a deformable loop).
Nakao discloses the attachment device (34) is a crimping mechanism for holding the plurality of legs together ([0059], [0061], [0063]) but fails to disclose it is deformable to secure the anchor component to the suture. However, in the same field of endeavor of an endoscopic suturing instrument, Vargas teaches an elongate member (endoscope) ([0011], [0015]) for delivering a suture and plurality of anchor components (Fig. 13), wherein a crimping mechanism in the form of a loop or bridge (161) (akin to the loop of attachment device 34 in Nakao) is provided and a suture is traversed therethrough (akin to the suture 11 traversed through the body 34 of Nakao). The crimping mechanism (161) is deformable to secure the anchor component (160) to the suture (115) (Fig. 1A; [0085]). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify Nakao such that the attachment device (crimping mechanism 34) is deformable to secure the anchor component to the suture as taught by Vargas to selectively lock the suture in the desired configuration and tension to approximate and repair tissue ([0004], [0005], [0080]).
Claim 8. The combination discloses the invention substantially as claimed above, wherein Nakao further discloses the delivery device (12) is extendable towards the target tissue (40) to position a distal most anchor (10) component of the plurality of anchor components adjacent the target tissue (Figs. 8-9; [0066]. [0067]).
Claim 9. The combination discloses the invention substantially as claimed above, wherein the delivery device (12) of Nakao is capable of being retractable towards the proximal end of the elongate member to deploy the anchor component of the plurality of anchor components. Applicant is reminded claim 9 is directed to an apparatus claim and not a method of use. Therefore, the structure of the prior art only needs to be capable of performing such a function. The device of Nakao uses a pusher (14) to deploy the plurality of anchor components. Therefore, if the pusher is held stationary, while the delivery device is retracted, the plurality of anchor components would be deployed and pushed out by the pusher ([0045]).
Claim 10. The combination discloses the invention substantially as claimed above, wherein Nakao further discloses each of the anchor components (10) of the plurality of anchor components comprises:
a plurality of legs (16) biasable from a first, collapsed configuration (Fig. 7; [0047]) to a second, expanded configuration upon deployment (Fig. 6; [0051]-[0053]); and
an attachment device (34) coupled to the plurality of legs, the attachment device directly connected to the suture ([0061]; “the body 34 might be provided with an opening through which line element 11 may traverse).
Claim 12. The combination discloses the invention substantially as claimed above, wherein it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention that the delivery device (12) of Nakao extends beyond the distal end of the elongate member (endoscope) as Nakao discloses the delivery device is passed through the endoscope and terminates in a sharp hollow tip (13) ([0045]). Therefore, the sharp hollow tip that is passed through must extend beyond the distal end of the endoscope to thereby use the tip (otherwise the tip would remain retracted within the endoscope).
Claim 13. Nakao discloses a suture device ([0016]), comprising:
an elongate member (endoscope) having a proximal end (end closer to user) and a distal end (end furthest from user), and defining a suture channel therethrough ([0044], flexible endoscope may include one or more channels; wherein the suture channel extends therethrough ([0045]; as tubular body 12 is passed through the endoscope, therefore the suture channel extends therethrough elongate member) ([0043]-[0045]);
a suture (11) extending through the suture channel ([0045], the suture is within delivery device 12, wherein the delivery device is within the suture channel (the channel in the endoscope containing this instrument)); and
a plurality of anchor components (10) coupled to the suture (Figs. 1-2, 6-9) ([0045]);
wherein:
the suture and the plurality of anchor components are deployable from the elongate member for engagement with a target tissue (40) (Figs. 8, 9; [0045], [0066], [0067]; and
at least one anchor component (10) of the plurality of anchor components comprises a plurality of legs (16) (Figs. 6, 7), and an attachment device (34) coupled to the plurality of legs and including a deformable loop surrounding the suture ([0061]; “the body 34 might be provided with an opening through which line element 11 may traverse”; by having an opening provided in the oval shape body 34, a loop is thereby formed from the body 34 (not shown). The body 45 may be formed of similar materials as legs 16, such as an elastic spring bias material or shape memory alloy as disclosed in [0054]. Therefore, since the body 34, in the form of a loop with an opening therethrough, is formed of an elastic material, it is thereby a deformable loop).
Nakao discloses the attachment device (34) is a crimping mechanism for holding the plurality of legs together ([0059], [0061], [0063]) but fails to disclose it is deformable to be secured to the suture. However, in the same field of endeavor of an endoscopic suturing instrument, Vargas teaches an elongate member (endoscope) ([0011], [0015]) for delivering a suture and plurality of anchor components (Fig. 13), wherein a crimping mechanism in the form of a loop or bridge (161) (akin to the loop of attachment device 34 in Nakao) is provided and a suture is traversed therethrough (akin to the suture 11 traversed through the body 34 of Nakao). The crimping mechanism (161) is deformable to be secured to the suture (115) (Fig. 1A; [0085]). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify Nakao such that the attachment device (crimping mechanism 34) is deformable to be secured to the suture as taught by Vargas to selectively lock the suture in the desired configuration and tension to approximate and repair tissue ([0004], [0005], [0080]).
Claim 14. The combination discloses the invention substantially as claimed above, wherein Nakao further discloses the attachment device (34) is directly connected to the suture ([0061]; “the body 34 might be provided with an opening through which line element 11 may traverse).
Claim 15. The combination discloses the invention substantially as claimed above, wherein Nakao discloses the deformable loop is sized to allow the suture to pass freely therethrough when undeformed ([0061]), and Vargas disclose the loop is deformable after the plurality of legs of the at least one anchor component are engaged with tissue ([0085]).
Claim 17. The combination discloses the invention substantially as claimed above, wherein Nakao further discloses the plurality of legs are biasable from a first, collapsed configuration (Fig. 7; [0047]) to a second, expanded configuration upon deployment (Fig. 6; [0051]-[0053]).
Claim 18. The combination discloses the invention substantially as claimed above, wherein Nakao further discloses comprising a delivery device (12) extending within the suture channel, the delivery device operable to deploy an anchor component of the plurality of anchor components ([0045], [0062], [0066], [0067]; Figs. 8-9).
Claim 19. The combination discloses the invention substantially as claimed above, wherein the delivery device (12) of Nakao is capable of being retractable towards the proximal end of the elongate member to deploy the anchor component of the plurality of anchor components. Applicant is reminded claim 19 is directed to an apparatus claim and not a method of use. Therefore, the structure of the prior art only needs to be capable of performing such a function. The device of Nakao uses a pusher (14) to deploy the plurality of anchor components. Therefore, if the pusher is held stationary, while the delivery device is retracted, the plurality of anchor components would be deployed and pushed out by the pusher ([0045]).
Claim 20. The combination discloses the invention substantially as claimed above, wherein it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention that the delivery device (12) of Nakao extends beyond the distal end of the elongate member (endoscope) as Nakao discloses the delivery device is passed through the endoscope and terminates in a sharp hollow tip (13) ([0045]). Therefore, the sharp hollow tip that is passed through must extend beyond the distal end of the endoscope to thereby use the tip (otherwise the tip would remain retracted within the endoscope).
Claim(s) 6, 11, 16 are is/are rejected under 35 U.S.C. 103 as being unpatentable over Nakao in view of Vargas as applied to claims 1, 7 and 13 above, and further in view of Mikkaichi et al (US 2007/0073321).
Claims 6 and 11. The combination discloses the invention substantially as claimed above, but fails to disclose an instrument extendable within the working channel of the elongate member, the instrument operable to deform the loop to secure the anchor component to the suture. Vargas teaches crimping, compressing, deforming the deformable loop (161) but fails to disclose how this is done.
However, in the same field of endeavor, Mikkaichi et al teaches an endoscopic suturing device for deploying a plurality of anchor components ([0033]), wherein a delivery device (13) containing a plurality of anchor components (27) disposed along a suture (25) is disposed within a suture channel (right channel 9 in Fig. 3) of an endoscope (1); the endoscope further defines a working channel (left channel 9 in Fig. 3) (Figs. 1-3; [0033]-[0035]). An instrument (forceps 60) is extendable within the working channel to manipulate and tighten the suture (akin to the crimping of the combination of Nakao in view of Vargas) (Figs. 12-13; [0042]). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the suture device to include an instrument extendable within the working channel of the elongate member, the instrument operable to deform the loop to secure the anchor component to the suture, based upon the teachings of Mikkaichi et al, to provide an instrument to perform the locking (crimping).
Claim 16. The combination discloses the invention substantially as claimed above, wherein Nakao further discloses elongate member further defines a working channel therethrough ([0044], flexible endoscope may include one or more channels; in the instance there are at least two channels, one is considered the working channel and the other is considered a suture channel), but fails to disclose the suture device further comprising an instrument extendable within the working channel of the elongate member, and operable to deform the loop to secure the anchor component to the suture.
However, in the same field of endeavor, Mikkaichi et al teaches an endoscopic suturing device for deploying a plurality of anchor components ([0033]), wherein a delivery device (13) containing a plurality of anchor components (27) disposed along a suture (25) is disposed within a suture channel (right channel 9 in Fig. 3) of an endoscope (1); the endoscope further defines a working channel (left channel 9 in Fig. 3) (Figs. 1-3; [0033]-[0035]). An instrument (forceps 60) is extendable within the working channel to manipulate and tighten the suture (akin to the crimping of the combination of Nakao in view of Vargas) (Figs. 12-13; [0042]). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the suture device to include an instrument extendable within the working channel of the elongate member, the instrument operable to deform the loop to secure the anchor component to the suture, based upon the teachings of Mikkaichi et al, to provide an instrument to perform the locking (crimping).
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1, 7 and 13 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 5 and 11 of U.S. Patent No. 12076002.
Although the claims at issue are not identical, they are not patentably distinct from each other because the elements of claims 1, 7 and 13 of the instant application are to be found in claims 5 and 11 of the patent. Thus the difference between claims 1, 7 and 13 of the instant application and claims 5 and 11 of the patent lies in the fact that the patent claims include many more elements and is thus much more specific. Thus, the invention of claims 5 and 11 of the patent is in effect a “species” of the “generic” invention of claims 1, 7 and 13 of the instant application. It has been held that the generic invention is “anticipated” by the “species”. See In re Goodman, 29 USPQ2d 2010 (Fed. Cir. 1993). Since claims 1, 7 and 13 are anticipated by claims 5 and 11 of the patent, it is not patentably distinct from claims 5 and 11 of the patent.
Conclusion
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/KATHERINE M SHI/Primary Examiner, Art Unit 3771