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 1 is objected to because of the following informalities: it is suggested to amend the limitation “switching the states” to read as “switching of the states”. Appropriate correction is required.
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, 7-9, 12 and 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.
With regards to claim 3, the claim states “one or more transmission gears” however the claim fails to clearly set forth a option of there being one or more transmission gears. It is suggested to overcome the rejection to change the limitation “a rack(s)” and “a transmission gear(s)” to read as “at least one rack” and “at least one transmission gear”. For examination purposes the claim is being interpreted based on the suggested claim language.
With regards to claim 7, the claim states “wherein two racks are fixed…” it is unclear if these two racks are in addition to the rack set forth in claim 3 or if the two racks are intended to further define the rack of claim 3. For examination purposes the claim is being interpreted as further defining the rack of claim 3.
With regards to claim 8, the claim states “wherein multiple groups of transmission gears…” it is unclear if these multiple groups are in addition to the transmission gear set forth in claim 3 or if the multiple groups are intending to further define the transmission gear of claim 3. Clarification and/or correction is required.
With regards to claim 9, the claim states “wherein the interventional instrument is a heart valve prosthesis” this renders the claim indefinite since it appears to be further defining an element that is not positively recited within the claim. Specifically, the interventional instrument is recited within intended use language “for crimping an interventional instrument” and therefore it not a required structure of the crimper.
With regards to claim 12, the claim states “wherein the power source is a knob and/or a motor” and then states “at least part of the knob…and the motor is located…” this renders the claim indefinite since the claim language allows for the option of just the knob, just the motor or both the knob and motor, however the limitations following the and/or phrase appears to require both the knob and the motor. Therefore the metes and bounds of the claim are indefinite since it is appears to encompasses a broad recitation, i.e. the and/or phrase, and a narrow recitation, i.e. both the knob and the motor, within the same claim. Clarification and/or correction is required.
With regards to claim 16, the claim states “the ring gear is provided with a plurality of blocking teeth in its own circumferential direction” this renders the claim indefinite since it is unclear what element is being referred to with the phrase “in its own”, i.e. the ring gear or blocking teeth. Clarification and/or 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.
1. Claim(s) 1-2, 5-6, 9-15 and 20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Sokel (US 7,415,861).
In reference to claim 1, Sokel discloses a crimper for crimping an interventional instrument, comprising
a housing (plates 126, 127) with a through instrument channel (135a, 135b) [see col. 5 line 60 – vol. 6 lines 6],
a plurality of force applying blocks (134) which are movably installed in the housing and distributed around the instrument channel, the plurality of force applying blocks have relative gathered and separated states and are configured to contact and expand the instrument channel during switching of the states [see 6 lines 7-27; figure 16], and
a ring gear (143) which is rotatably matched with the housing and configured to synchronously drive the plurality of force applying blocks (134) to switch the states [see col. 6 lines 28-33; figure 20b].
In reference to claim 2, the crimper further comprises a transmission mechanisms (pins 147), and each transmission mechanism is connected between the ring gear (143) and a corresponding force applying block (134) in a transmission manner [see figure 21A; col. 6 lines 28-44].
In reference to claim 5, the ring gear (143) comprises an annular portion and driving teeth (144) distributed on the annular portion in a transmission fit with the force applying blocks (134), and the driving teeth (144) are configured as outer teeth distributed on an outer periphery of the annular portion, as seen in figures 20b and 21A.
In reference to claim 6, the ring hear (143) surrounds an outer periphery of the plurality of force applying blocks (134), as seen in figure 17.
In reference to claim 9, the interventional instrument is a heart valve prothesis [see col. 1 lines 3-12].
In reference to claim 10, the crimper further comprises a driving mechanism for driving the ring hear (143), and the driving mechanism is a driving handle (152) directly connected to the ring gear, as seen in figure 20B.
In reference to claim 11, the crimper further comprises a driving mechanism for driving the ring gear (143) to rotate, the driving mechanism is a driving shaft (148), which has at least a part located in the housing and linked with the ring gear and at least a part for connecting a power source (handle 152), and a rotation axis of the driving shaft is parallel to a rotation axis of the ring gear, as seen in figure 20B.
In reference to claim 12, the power source is a knob, as seen in figure 20B [knob is located at distal end of handle], at least part of the knob is exposed out of the housing, and the knob and the driving shaft are formed as separate pieces.
In reference to claim 13, an operation window (spacing between plates 126, 127) is opened in the housing, and at least a part of the ring gear (143) is exposed to the operation window and connected to the driving handle, as seen in figure20A.
In reference to claim 14, the driving handle (152) comprises a holding portion and a snapping portion, and the ring gear is provided with a snapping slot that matches the snapping portion [teeth of pinion gear 150 and teeth of ring gear are considered to be the snapping portion and slot].
In reference to claim 15, the housing (126, 127) is in a shape of a hollow disc, the instrument channel extends through an axis of the disc, an interior of the housing is an installation chamber, and the ring gear (143) and the force applying blocks (134) are all located in the installation chamber, as seen in figure 17.
In reference to claim 20, Sokel discloses a method for loading an interventional instrument, comprising the steps of
providing a crimper which comprises:
a housing (plates 126, 127) with a through instrument channel (135a, 135b) [see col. 5 line 60 – vol. 6 lines 6],
a plurality of force applying blocks (134) which are movably installed in the housing and distributed around the instrument channel, the plurality of force applying blocks have relative gathered and separated states and are configured to contact and expand the instrument channel during switching of the states [see 6 lines 7-27; figure 16], and
a ring gear (143) which is rotatably matched with the housing and configured to synchronously drive the plurality of force applying blocks (134) to switch the states [see col. 6 lines 28-33; figure 20b],
placing the interventional instrument in the instrument channel,
rotating the ring gear (143) to drive the plurality of force applying blocks (134) to move synchronously to crimp the interventional instrument, and
transferring the crimped interventional instrument into a sheath for loading the interventional instrument [see col. 4 lines 48-62].
2. Claim(s) 1-2, 5, 9-12 and 17-20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Spenser et al (US 2007/0061009).
In reference to claim 1, Spenser et al discloses a crimper for crimping an interventional instrument, comprising
a housing with a through instrument channel [see figure 11a],
a plurality of force applying blocks (11) which are movably installed in the housing and distributed around the instrument channel, the plurality of force applying blocks have relative gathered and separated states and are configured to contact and expand the instrument channel during switching of the states [see paragraph 0050-0052 & 0069], and
a ring gear (3) which is rotatably matched with the housing and configured to synchronously drive the plurality of force applying blocks (134) to switch the states [see paragraph 0069; figure 11a].
In reference to claim 2, the crimper further comprises a transmission mechanisms (11), and each transmission mechanism is connected between the ring gear (3) and a corresponding force applying block (1) in a transmission manner [see figure 11a].
In reference to claim 5, the ring gear (3) comprises an annular portion and driving teeth distributed on the annular portion in a transmission fit with the force applying blocks (134), and the driving teeth (144) are configured as outer teeth distributed on an outer periphery of the annular portion, as seen in figures 11b.
In reference to claim 9, the interventional instrument is a heart valve prothesis [see paragraph 0046].
In reference to claim 10, the crimper further comprises a driving mechanism for driving the ring hear (3), and the driving mechanism is a driving handle (98) directly connected to the ring gear, as seen in figure 11a [see paragraph 0069].
In reference to claim 11, the crimper further comprises a driving mechanism for driving the ring gear (3) to rotate, the driving mechanism is a driving shaft (96), which has at least a part located in the housing and linked with the ring gear and at least a part for connecting a power source (knob 98), and a rotation axis of the driving shaft is parallel to a rotation axis of the ring gear, as seen in figure 11b.
In reference to claim 12, the power source is a knob (98), at least part of the knob is exposed out of the housing, and the knob and the driving shaft are formed as separate pieces, as seen in figure 11b.
In reference to claim 17, at least one of the force applying blocks (1) is provided with an indicator [broadest reasonable interpretation is the indicator is the visible surface within the window opening], and the housing is provided with a view port corresponding to the indicator, as seen in figure 12.
In reference to claim 18, the indicator and the corresponding force applying block (1) are formed in one piece, and the indicator is located on one side of the corresponding force applying block in an axial direction of the housing, as seen in figure 12.
In reference to claim 19, the crimper further comprises a shifter (108) movably installed in the housing and having a plurality of working positions, wherein the shifter is configured to cooperate with a corresponding limiting structure at each working portion to limit rotation of the ring gear [see figure 12; paragraph 0070-0071].
In reference to claim 20, Spenser et al discloses a method for loading an interventional instrument, comprising the steps of
providing a crimper which comprises:
a housing with a through instrument channel [see figure 11a],
a plurality of force applying blocks (11) which are movably installed in the housing and distributed around the instrument channel, the plurality of force applying blocks have relative gathered and separated states and are configured to contact and expand the instrument channel during switching of the states [see paragraph 0050-0052 & 0069], and
a ring gear (3) which is rotatably matched with the housing and configured to synchronously drive the plurality of force applying blocks (134) to switch the states [see paragraph 0069; figure 11a].
placing the interventional instrument in the instrument channel,
rotating the ring gear (3) to drive the plurality of force applying blocks (1) to move synchronously to crimp the interventional instrument, and
transferring the crimped interventional instrument into a sheath for loading the interventional instrument [see paragraph 0072-0073].
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) 3-4, 7-8 and 16-18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sokel.
In reference to claims 3-4 and 7-8, Sokel discloses the transmission of the force applying blocks is obtained by a pin and slot configuration where rotational movement is transmitted to linear movement. Sokel discloses the invention substantially as claimed except for wherein the transmission is obtained by a rack and pinion.
However, it is well known in the art that a slot and pin configuration and a rack and pinion (gear) configuration are known equivalents in the art for translating rotational movement into linear movement.
Therefore it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the slot and pin configuration of Sokel with a rack and gear configuration, since both are well known equivalent and the same resulting motion of the force applying blocks would be obtained.
In reference to claim 16, Sokel discloses the invention substantially as claimed except for wherein the crimper comprises an elastic piece that cooperates with teeth on the ring gear to make noise as the ring gear rotates.
However, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to provide an elastic piece to engage with teeth on the ring gear to obtain the predictable result of communicating activation of the ring gear with an operator by a physical noise [KSR Int’l Co. v. Teleflex Inc., 127 S.Ct. 1727, 1742, 82 USPQ2d 1385, 1396 (2007)].
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Debra Sullivan whose telephone number is (571)272-1904. The examiner can normally be reached Monday-Friday 8am-4:30pm EST.
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/Debra M Sullivan/
Primary Examiner, Art Unit 3725
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