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.
Claim 20 is 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 20 recites “the suture lock” and “the adaptor” in line 3. There is insufficient antecedent basis for these limitations in the claims. Claim 20 depends from claim 1, which does not provide proper antecedent basis. It is unclear if claim 20 should depend from claim 1 as written or is intended to depend from claim 17 which does recite a suture lock and adaptor. For the purpose of examination, the claim will be interpreted as depending form claim 1 as written and the suture lock/adaptor will be interpreted as equivalent to the first and second component of claim 1.
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 and 4-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kao (WO 2011/156533).
Regarding claim 1, Kao discloses a handle assembly (FIG 10F, [0071-0076]) for a delivery apparatus configured to deliver a prosthetic implant (The coupling/locking mechanism of FIG 10F is described as being used in the delivery system to releasably coupled the shuttle sheath with the inner or outer shaft, which as previously described are elements of the stent delivery device), the handle assembly comprising: a first component comprising a male connection portion (1036), wherein the male connection portion comprises a main body (1038) with a pin (1042) extending radially outwardly from the main body (FIG 10F); a second component comprising a female connection portion (1026) configured to receive the male connection portion of the first component ([0073]), wherein the female connection portion comprises an inner surface defining an inner bore (1040), a slot (1028) extending along the inner surface (Because the slot extends form the inner to outer surface to form the channel), and a retaining portion (1034) connected to the slot (FIG 10F) and configured to receive the pin ([0074]), wherein the first component and the second component are movable between a locked configuration (when 1038 is received within 1040 and pin 1042 is received within 1034) and a release configuration (Wherein 1042 is disengaged from receiver 1034) by inserting the main body into the inner bore and rotating the male connection portion relative to the female connection portion less than one revolution about an axial axis of the main body (Rotating the male connection portion along the length of 1032 until the pin moves from 1030 into 1034, [0074-0076]; this distance is less than a full revolution), wherein in the locked configuration, the pin is positioned within the retaining portion ([0074] “pin 1042 then nests in receiver 1034, locking the male and female connectors together”) and the slot is configured to resist rotational movement of male connection portion relative to the female connection portion ([0074] “The spring force may be used to ensure that the pin 1042 then nests in receiver 1034. In addition or alternatively, the spring force may be used to maintain the pin 1042 within or in an engaged configuration with a suitable detent, notch, or locking feature located in a slot or within the female coupling”) and wherein in the release configuration, the pin is positioned within the slot (When the pin is removed from 1034, it is positioned in within the slot, thereby defining the release configuration).
Regarding claim 4, Kao discloses the slot comprises an axial portion (1030) extending parallel to the axial axis (FIG 10F) and a circumferential portion (1032) connected to the axial portion and extending circumferentially about the axial axis (FIG 10F), wherein the retaining portion is connected to a terminal end of the circumferential portion (FIG 10F).
Regarding claim 5, Kao discloses the circumferential portion comprises a deflectable portion adjacent to the retaining portion such that the deflectable portion can be dilated when the pin is received in the deflectable portion ([0074] “The slot may also include one or more appropriately placed notches, indentations, detents, slits, or grooves to aid in maintaining one or more pins in a specific location along any of the sections of a slot” and [0075] “A friction fit may be introduced along the slot by, for example, reducing the diameter of the slot relative to the diameter or size of one or more pins so when the pin or pins move into a reduced size or diameter section of the slot, the pin is wedged into that position”. The slot has a narrowed diameter which is dilated/deflected as the pin passes therethrough to reach the retaining portion).
Regarding claim 6, Kao discloses the female connection portion comprises at least one relief channel extending parallel to the circumferential portion and configured to allow the deflectable portion to axially dilate when the pin moves through the deflectable portion ([0074] disclosing notches, indentations, detents, slits, or grooves to aid in maintaining one or more pins in a specific location, thereby forming at least on relief channel which allows for the flexing of the materials).
Regarding claim 7, Kao discloses the female connection portion comprises a deformable material around the deflectable portion such that when the pin moves through the deflectable portion, the pin can compress the deformable material and axially dilate the deflectable portion (The slot being formed with notches, indentations, detents, slits, or grooves to aid in maintaining one or more pins in a specific location along any of the sections of a slot is interpreted as having a deformable material which flexes to allow passage of the pin through the slot when a sufficient force is applied).
Regarding claim 8, Kao discloses the pin is a second pin (FIG 10F shows a second pin 1042) and the slot is a second slot ([0071] “ The female connector 1026 includes a central channel 1040 and at least one, and preferably two or more slotted channels 1028 that extend through a sidewall of the female connector 1026”), wherein the male connection portion comprises a first pin (FIG 10F shows a first pin) extending radially outwardly from the main body (FIG 10F), wherein the first pin is axially offset from the second pin by a predefined distance (Because it is integrally formed with 1038, see distance in FIG 10F), wherein the female connection portion comprises a first slot configured to receive the first pin ([0071] there is an additional slot to receive the additional pin).
Regarding claim 9, Kao discloses the first slot comprises (The additional slot is understood to be identical to the slot visible in FIG 10F) an axial portion extending parallel to the axial axis (1030) and a circumferential portion extending circumferentially about the axial axis (1032), wherein the axial portion has an axial length equal to the predefined distance (At least some length of the portion can be taken which is equal to a predefined distance. [0071] discloses “ the relative length, size and orientation of the each of the sections 1030, 1032, 1034 of a coupler may vary depending upon a number of design factors”).
Regarding claim 10, Kao discloses the male connection portion comprises a third pin extending radially outwardly from the main body ([0073] discloses “preferably two or more pins 1042 extend radially outward from the elongate distal portion 1038”), wherein the female connection portion comprises a third slot configured to receive the third pin ([0071] discloses “preferably two or more slotted channels 1028 that extend through a sidewall of the female connector 1026”).
Regarding claim 11, Kao discloses the first pin and the third pin are positioned at circumferentially opposite sides of the second pin (Due to the circumferential arrangement of the pins, a first and third pin can be viewed as on opposite sides of a second pin).
Regarding claim 12, Kao discloses the third slot comprises (The additional slot is understood to be identical to the slot visible in FIG 10F) an axial portion extending parallel to the axial axis (1030) and a circumferential portion extending circumferentially about the axial axis (1032), wherein the circumferential portion of the third slot is axially aligned with the circumferential portion of the first slot (The slots are located at the same axial position along the body of 1026).
Regarding claim 13, Kao discloses the retaining portion comprises a radially recessed detent relative to the slot and the inner surface the female connection portion (“rounded out portion 1035”, [0074]).
Regarding claim 14, Kao discloses the slot comprises a radial protrusion adjacent to the radially recessed detent ([0074] discloses the slot having “notches, indentations, detents, slits, or grooves” which is interpreted as a radial protrusion).
Regarding claim 15, Kao discloses the radial protrusion is configured to be radially depressible such that the radial protrusion can be radially compressed to allow the pin to move across the radial protrusion (The detents and grooves are understood to be compressible in order to allow for the passage of the pin through the slot while providing resistance).
Regarding claim 16, Kao discloses the pin being configured to be deformable such that the pin can be radially compressed when moving across the radial protrusion (the pin is understood to be at least configured to compress in order to allow for the pin to pass through the obstructions created in the slot and receiver section such as the notches, indentations, detents, slits, or grooves).
Regarding claim 20, Kao discloses a method of implanting a prosthetic implant (FIG 15A-15F, wherein 128 is the prosthetic implant, [0114]), the method comprising: assembling a handle assembly according to claim 1 (Thus resulting in the device of FIG 15), wherein the assembling comprises rotating the suture lock relative to the adaptor (As stated above in the rejection under 35 SUC 112(b), suture lock and adaptor are interpreted to mean the first and second component) in the first direction so as to connect the suture lock to the adaptor (FIG 15A-15D show rotation of one body relative to the other such that the pin is removed from the slot and results in disconnection. Therefore, achieving the assembled state of FIG 15A required the reverse rotation).
Regarding claim 17, Kao discloses handle assembly (FIG 10F, [0071-0076]) for a delivery apparatus configured to deliver a prosthetic implant (The coupling/locking mechanism of FIG 10F is described as being used in the delivery system to releasably coupled the shuttle sheath with the inner or outer shaft, which as previously described are elements of the stent delivery device), the handle assembly comprising: a suture lock (1036) configured to connect to a release suture which is tied to the prosthetic implant (The release suture and prosthetic implant are not positively recited elements of the claim, therefore the element interpreted as a suture lock need only be capable of achieving the function of locking a suture. 1036 is at least configured to lock a suture if the suture where wrapped around the circumferential body for example, and compressed between against the inner lumen of 1026 upon insertion of one element into the other); and an adaptor (1026) comprising a lumen (1040) configured for the release suture to extend through (central channel 1040 is at least configured to contain a portion of a suture therein) and an end portion (body of the annular wall at the proximal end of 1026 which engages with 1038) configured to be releasably connected to a connecting portion (distal end of 1036) of the suture lock via a lock and release mechanism (pin and slot , [0071-0075]), wherein the lock and release mechanism comprises a peg (1042) and a slot (1028) configured to receive the peg ([0074]), wherein the slot comprises a deflectable portion ([0074] “The slot may also include one or more appropriately placed notches, indentations, detents, slits, or grooves to aid in maintaining one or more pins in a specific location along any of the sections of a slot” and [0075] “A friction fit may be introduced along the slot by, for example, reducing the diameter of the slot relative to the diameter or size of one or more pins so when the pin or pins move into a reduced size or diameter section of the slot, the pin is wedged into that position”. The slot has a narrowed diameter which is dilated/deflected as the pin passes therethrough to reach the retaining portion) and a retaining portion (1034) connected to the deflectable portion (FIG 10F), wherein the retaining portion is configured to retain the peg ([0073-0074]), wherein the deflectable portion has a smaller diameter than the peg ([0075] “A friction fit may be introduced along the slot by, for example, reducing the diameter of the slot relative to the diameter or size of one or more pins so when the pin or pins move into a reduced size or diameter section of the slot, the pin is wedged into that position”), wherein rotation of the suture lock relative to the adaptor in a first direction is configured to move the peg through the deflectable portion and lock into the retaining portion such that the deflectable portion inhibits the peg from moving out of the retaining portion ([0074-0075]), wherein rotation of the suture lock relative to the adaptor in a second direction opposite to the first direction is configured to move the peg out of the retaining portion through the deflectable portion ([0076]).
Regarding claim 18, Kao discloses when connected, the connecting portion of the suture lock and the end portion of the adaptor are coaxial about an axial axis (See longitudinal axis in FIG 10F. The connecting portion and end portion are aligned along the same axis in the connected state as well).
Regarding claim 19, Kao discloses the slot comprises a first slot portion extending parallel to the axial axis (1030) and a second slot portion (1032) connecting to the first slot portion at a corner (FIG 10F) and extending circumferentially about the axial axis (FIG 10F), wherein the second slot portion comprises the deflectable portion ([0074]) and the retaining portion (1034) is located at a terminal end of the second slot portion (FIG 10F).
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.
Claim(s) 2-3 are rejected under 35 U.S.C. 103 as being unpatentable over Kao (WO 2011/156533) in view of Leanna et al. (US 2009/0182407).
Regarding claim 2, Kao discloses the invention substantially as claimed as set forth above for claim 1.
Kao is silent regarding the first component comprises a spool configured to connect to a release suture which extends through the inner bore of the second component and is tied to the prosthetic implant.
However, Leanna et al. discloses a handle assembly (Proximal end shown in FIG 1) for a delivery apparatus (10) configured to deliver a prosthetic implant (12, [0023]), the handle having a first component (28) comprising a spool (66, 70, FIG 8-9); which function as a spool because [0048] discloses the two ends of the loading suture 30 can be wrapped around either threaded cylindrical port 70, 66 before being secured by the cap 64) configured to connect to a release suture (30) which extends through an inner bore (lumen) of a second component (24, see passage in FIGs 3 and 6) and is tied to the prosthetic implant (12, FIG 4).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify the first component of Kao to comprise a spool configured to connect to a release suture which extends through the inner bore of the second component and is tied to the prosthetic implant, as taught by Leanna, for the purpose of configuring the delivery apparatus such that it can comprise a suture connected to the prosthetic implant to aid in positioning of the stent prior to delivery ([0045]).
Regarding claim 3, Kao discloses the invention substantially as claimed as set forth above for claim 1.
Kao is silent regarding the second component comprises a spool configured to connect to a release suture which extends through a lumen of the first component and is tied to the prosthetic implant.
However, Leanna et al. discloses a handle assembly (Proximal end shown in FIG 1) for a delivery apparatus (10) configured to deliver a prosthetic implant (12, [0023]), the handle having a second component (28) comprising a spool (66, 70, FIG 8-9); which function as a spool because [0048] discloses the two ends of the loading suture 30 can be wrapped around either threaded cylindrical port 70, 66 before being secured by the cap 64) configured to connect to a release suture (30) which extends through a lumen (lumen of 22) of a first component (24, see passage in FIGs 3 and 6) and is tied to the prosthetic implant (12, FIG 4).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify the second component of Kao to comprise a spool configured to connect to a release suture which extends through a lumen of the first component and is tied to the prosthetic implant, as taught by Leanna, for the purpose of configuring the delivery apparatus such that it can comprise a suture connected to the prosthetic implant to aid in positioning of the stent prior to delivery ([0045]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BROOKE N LABRANCHE whose telephone number is (571)272-9775. The examiner can normally be reached M-F 8-5.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Elizabeth Houston can be reached at 5712727134. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BROOKE LABRANCHE/Primary Examiner, Art Unit 3771
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