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 10-11 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.
Regarding claims 9-11, the language is unclear about the relationship between the clamp and stationary platform. Does the stationary platform encompass the clamp or is the stationary platform part of the clamp? Further clarification is needed.
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.
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.
Claim(s) 1 is/are rejected under 35 U.S.C. 103 as being unpatentable over multiple embodiments Drake (US 9480839 B2).
Regarding claim 1, Drake discloses a lead delivery system (eg. Fig. 1, abstract, Col. 1, Ln. 36-50) comprising: a lead delivery device (eg. Fig. 1-2 lead delivery device) including: a trigger configured to activate a lead advancer to advance a lead into a patient (eg. multiple embodiments Col. 3, Ln. 35-55 Col. 17, Ln. 5-16, Col. 19, Ln. 30-55, hydraulic pressure trigger, Col. 13, Ln. 30-55, claim 1); and a cannula configured to receive the lead (eg. Col. 8, Ln. 14-48 cannulated catheter), the cannula extending through the lead delivery device and having a distal end through which the lead is deployed into the patient (eg. Col. 8, Ln. 14-48, lead guided over the guidewire to target site 82).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have combined/modified multiple embodiments of the trigger and drive mechanisms such as the hydraulic pressures and advancement member to provide predictable and known alternative ways to bring a lead through a cannula.
Claim(s) 2-8, and 15-16 is/are rejected under 35 U.S.C. 103 as being unpatentable over multiple embodiments Drake (US 9480839 B2) in view of Chin (US 2004/0102804 A1).
Regarding claim 2, Drake discloses the invention of claim 1, but does not disclose the system configured to variably control a size of a cannula opening.
Chin teaches an endoscopic introducer device that has an expandable sheath (eg. Para 148-158 Fig. 1-3).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have combined the invention of Drake with the expandable sheath as taught by Chin to provide the predictable result of having flexibility of accommodating different sizes of instruments being introduced to the body.
Regarding claims 3 and 15, the combined invention of Drake and Chin discloses the cannula is configured to expand (eg. Chin, Fig. 1C-E and 15, 124, Para. 148-158).
Regarding claim 4, the combined invention of Drake and Chin discloses the cannula is configured to separate (eg. Chin, Fig. 1C-E, 124 and Fig. 15, Para. 148-158).
Regarding claim 5, the combined invention of Drake and Chin discloses cannula having two cannula halves (eg. Chin, Fig. 1C, halves of the cannula).
Regarding claim 6, the combined invention of Drake and Chin discloses having multiple cannula segments (eg. Chin, Fig. 1C-E, 124 and Fig. 15, Para. 148-158).
Regarding claim 7, the combined invention of Drake and Chin discloses comprising one or more of a screw, an adjustable latch, a ratcheting mechanism, or a lever to control the size of the cannula opening (eg. Chin, Para. 28, 190, Fig. 1 and 15, lever, one of ordinary skill could use a multitude of different mechanisms such as adjustable latches or levers to control the dilation of the cannula since these are well-known mechanisms in the art).
Regarding claim 8, the combined invention of Drake and Chin discloses a second cannula allowing simultaneous delivery of components into the patient (eg. Chin, Para. 23-24, 62, 222, second instrument/incision/access port).
Regarding claim 16, the combined invention of Drake and Chin discloses an expandable sheath, wherein the cannula is further configured to expand within the sheath and allow the lead to pass through the cannula (eg. Chin, Fig. 1C-E and 15, 124, Para. 34-35 outer expandable sheath, 148-158).
Claim(s) 9-14 is/are rejected under 35 U.S.C. 103 as being unpatentable over multiple embodiments Drake (US 9480839 B2) in view of Chin (US 2004/0102804 A1), further in view of yee (US 8876712 B2).
Regarding claim 9, Drake discloses the invention of claim 1, but does not disclose a stationary platform for engaging the anatomy of the patient.
Yee teaches an intracardiac sheath stabilizer that has a base that can be held against an exterior chest wall (eg. Abstract, Col. 2, Ln. 55 – Col. 3, Ln. 20, Col. 4, Ln. 18-45, Fig. 9A-B).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have combined the invention of Drake to have a stationary base with the tubular sheath as taught by Yee to provide the predictable result of helping stabilize the device to a patient anatomy. One of ordinary skill could use that same tube and anchor system to also move leads in combination with the surgical elements.
Regarding claim 10, the combined invention of Drake and Yee discloses a clamp configured to secure the delivery system to one or more anatomical structures of a patient (eg. Chin, clamp Para. 12, 243, 282 and Yee, Col. 5, Ln. 19-31, Col. 6, Ln. 64 – Col. 7, Ln. 15).
Regarding claim 11, the combined invention of Drake and Yee discloses the clamp comprising the stationary platform and a hook portion configured to extend or retract in relation to the stationary platform Col. 6, Ln. 64 – Col. 7, Ln. 30, Col. 9, Ln. 3-64).
Regarding claim 12, the combined invention of Drake and Yee discloses the cannula is located proximate the stationary platform (eg. Yee Col. 6, Ln. 64 – Col. 7, Ln. 15, Fig. 9A-B).
Regarding claim 13, the combined invention of Drake and Yee discloses the lead delivery device configured to adjust a distance between the distal end of the cannula and the stationary platform (eg. Yee, Col. 7, Ln. 32-48, Col. 9, Ln. 40-52, Col. 13, Ln. 55 – Col. 14, Ln. 6, Fig. 5, Col. 7, Ln. 30-65 different links).
Regarding claim 14, the combined invention of Drake and Yee discloses delivery device including one or more of a screw, an adjustable latch, or a ratcheting mechanism that adjusts the distance between the distal end of the cannula and the stationary platform (eg. Yee, Col. 7, Ln. 32-48, Col. 9, Ln. 40-52, Col. 13, Ln. 55 – Col. 14, Ln. 6, Fig. 5, Col. 7, Ln. 30-65 different links, One of ordinary skill could use the mechanisms as taught by Yee as a known alternative to changing the distance between the base and the distal end of the cannula).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL J LAU whose telephone number is (571)272-2317. The examiner can normally be reached 8-5:30 PM.
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/MICHAEL J LAU/Examiner, Art Unit 3796
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