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
Claim 15 is objected to because of the following informalities: “one or more brace member” should state “one or more brace members”. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-10 and 12-16 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Independent claim 1 has been amended to state “the proximal portion substantially surrounds the endoscopic device”. The written description does not disclose the term “substantially surrounds”.
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 1-10 and 12-16 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.
The term “substantially surrounds” in claim 1 is a relative term which renders the claim indefinite. The term “substantially” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. The written description does not disclose the term “substantially surrounds”. The upper and lower bounds for what is considered “substantially surrounds” is unclear.
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.
Claim(s) 1-4, 6 and 13-15 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Gambale et al (2003/0167062).
Regarding claim 1, Gambale et al disclose a loading device for coupling an accessory device to an endoscopic device, the loading device comprising:
a main body with a longitudinal axis (clip delivery/locking device is shown generally as 1 – [0222]), a proximal portion for receiving an endoscopic device (device 1 is shown in an embodiment designed for mounting to the distal end of an endoscope 18 – [0222]) and a distal portion for receiving an accessory device (suture clip assembly comprising in the illustrated embodiment, a plug 3 and a ring 8 – [0223]), wherein the proximal portion is movable into a closed configuration wherein the proximal portion substantially surrounds the endoscopic device and the distal portion is longitudinally spaced from the proximal portion and includes an opening for receiving the accessory device (figs.1A-1D); and
a passage extending along a longitudinal axis of the main body such that the endoscopic device may be coupled to the accessory device within the passage (opening in which the pusher 14 of endoscope 18 travels through to push the suture clip assembly - fig.1. Examiner notes “may be coupled” is optional language which does not provide any further patentable weight.).
Regarding claim 2, Gambale et al disclose further comprising a fixation element for holding the endoscope in a fixed position relative to the main body (flange 17 is adapted to conform to the contours of the exterior surface of endoscope 18…device 1 can be secured to endoscope 18 with mechanical fasteners – [0222]).
Regarding claim 3, Gambale et al disclose wherein the proximal portion of the main body comprises first and second portions movable relative to each other between open and closed positions (secured to endoscope with mechanical fasteners – [0222]).
Regarding claim 4, Gambale et al disclose wherein the first and second portions hold the endoscopic in the fixed position in the closed position (the combination of the proximal end of device 1 interfacing with the distal end and flange 17 interfacing with the exterior surface of the endoscopic effectively locks device 1 to endoscope 18. Alternatively, device 1 can be secured to endoscope 18 with mechanical fasteners – [0222]).
Regarding claim 6, Gambale et al further comprising a positioning element coupled to the main body for aligning a portion of the endoscopic device with a portion of the loading device, wherein the positioning element is configured to align the endoscopic device with the main body relative to the longitudinal axis (proximal opening of clip delivery/locking device – fig.1).
Regarding claim 13, Gambale et al disclose wherein the proximal portion of the main body comprise a gripping surface (exterior surface of clip delivery/locking device 1 – fig.1).
Regarding claim 14, Gambale et al disclose wherein the proximal portion of the main body comprises a locking feature, the locking feature configured to lock the proximal portion of the loading device in the closed position (locking device – [0222]).
Regarding claim 15, Gambale et al disclose wherein the loading device further comprises one or more brace members extending laterally from the main body, the brace members being configured to brace the loading device against a surface (tapered finger ends – [0224], fingers extend radially when suture is deployed – figs.1B-1D).
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.
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) 5 and 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gambale et al (2003/0167062) in view of Menn (2008/0281299).
Regarding claim 5, Gambale et al disclose a first portion and a second portion, but fail to explicitly disclose a hinge.
However, Menn teaches in the same medical field of endeavor, a hinge rotatably coupling a first portion to a second portion (concavity 70a flexible connects (e.g., by a living hinge) the first lobe 40a to the third lobe 50a, and concavity 70b flexibly connects (e.g., by a living hinge) the second lobe 40b to the forth lobe 50b – [0032]; fig.1; wherein a concavity hingedly connects said upper clip body to said lower clip body – claim 18).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the first portion and second portion of Gambale et al with a hinge as it would provide a well-known and conventional structure for opening and closing (i.e., from an unlocked to a locked configuration).
Regarding claim 12, Gambale et al disclose the invention substantially as claimed, but fail to explicitly disclose wherein the main body comprises an inner surface and one or more protrusions extending from the inner surface to stabilize the endoscopic device within the channel.
However, Menn discloses wherein the main body comprises an inner surface and one or more protrusions extending from the inner surface to stabilize a device within the channel (knurled surface 30 may include generally elongated protrusions 30a extending in a direction generally perpendicular to the first diameter – [0029]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the inner surface and one or more protrusions to stabilize a device with stabilizing the endoscopic device as it would provide a mere duplication of parts to provide a surface which restricts rotation of the endoscope.
Claim(s) 7-10 and 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gambale et al (2003/0167062) in view of Stefanik et al (2006/0258907).
Regarding claim 7, Gambale et al disclose a positioning element, but fail to explicitly disclose a positioning element extends laterally from the main body and comprises one or more visual indicators.
However, Stefanchik et al teach in the same medical field of endeavor, a positioning element (tabs 330 can be employed to stabilize the track 300 with respect to the endoscope when the endoscope is positioned in the sheath 200 – [0090]), wherein the positioning element extends laterally from the main body (tabs 330) and comprises one or more visual indicators (flexible indicator tab 536 – [0101]; fig.7).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the loading device of Gambale et al with a positioning element extending laterally from the main body and one or more visual indicators of Stefanchik et al as it would provide stabilization of the endoscopic device with respect to the main body. Regarding claims 8 and 9, Gambale et al disclose the invention substantially as claimed, but fail to explicitly disclose a guide element.
However, Stefanchik et al teach in the same medical field of endeavor, a guide element on a proximal portion of a main body for guiding an accessory device through a distal opening and into a passage (track 300 – fig.1a), wherein the guide element comprises first and second guide tracks formed on a distal portion of the main body (relatively more flexible portion of the track distally of a relatively less flexible portion of the track. The track comprises at least three regions – [0015]. Each adjacent region is considered a separate track.); and wherein the guide tracks are laterally spaced from the passage and extend at an angle relative to the longitudinal axis (fig.1a).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the loading device of Gambale et al with a guide element which comprises first and second guide tracks as it would provide stabilization of the endoscopic device with respect to the main body.
Regarding claim 10, Menn discloses the invention substantially as claimed but fail to explicitly disclose an indicator.
However, Stefanchik et al teach in the same medical field of endeavor, an indicator coupled to the main body and configured to provide an indication that an accessory device is coupled to an endoscopic device (flexible indicator tab 536 – [0101]), wherein the indicator provides an audible or tactile signals when the accessory device is coupled to the endoscopic device (the indicator would provide tactile signals as the user would feel the carrier ceasing to move).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the loading device of Gambale et al with an indicator as it would provide notification of securing the endoscopic device to the endoscope.
Regarding claim 16, Gambale et al disclose the loading device substantially as claimed, but fail to explicitly disclose a fixation device.
However, Stefanchik et al teach in the same medical field of endeavor, a fixation element for securing an accessory device to the main body, wherein the fixation element comprises a lateral extension rotatably coupled to a main body and movable between open and closed positions (hinged latch 140 – fig.1a (rotated open), fig1b (rotated closed)).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the securing of the accessory device to the main body of Gambale et al with a fixation element comprising a lateral extension rotatably coupled to the main body as it would provide a well-known and conventional structure for securing the accessory device to the main body.
Allowable Subject Matter
Claims 17-23 are allowed.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-10 and 12-16 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
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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/ROCHELLE D TURCHEN/Primary Examiner, Art Unit 3797