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 10 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 10 recites the limitation "the flexible tip" in line 1. There is insufficient antecedent basis for this limitation in the claim. For examination purposes, claim 10 is being interpreted as depending from claim 9 which provides proper antecedent basis. Appropriate correction is required.
Claim Rejections - 35 USC § 102
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.
Claims 1-3, 5, 6, 8, and 11 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Mueller (US 20110060333 A1).
Regarding claim 1 Mueller discloses (fig. 1 and 5-9) an aortic septotomy device for cutting aortic tissue between a true lumen and a false lumen (the device is capable of cutting aortic tissue between a true lumen and a false lumen), the aortic septotomy device comprising:
a handle device (20+30) having a jaw actuator member 40 (see [0031] and [0035]);
a distal head assembly 400 having a pair of jaw members (402, 404, see fig. 5 and [0055]) movable between an opened position and a clamping position (see [0056]) and a cutting mechanism 410 movable within a channel 482 (see [0056]); and
a sheath member 12 extending from the handle device (20+30) to the distal head assembly 400 (shown as 100 in fig. 1, see [0032]);
wherein at least one of the pair of jaw members (402, 404) is movable in response to actuation of the jaw actuator member 40 to selectively grasp aortic tissue (see [0036] and [0057]), and the cutting mechanism 410 is movable within the channel 482 to cut at least a portion of the aortic tissue while the pair of jaw members grasps the aortic tissue (see [0056] and [0059]).
The Office notes that fig. 5-9 only show a different embiodment of the end effector assembly but the rest of the device is as shown in fig. 1 (see [0055]).
The language, preamble "an aortic septotomy device for cutting aortic tissue between a true lumen and a false lumen" merely recites intended uses of the apparatus. The claim, however, is an apparatus claim, and is to be limited by structural limitations. The Office submits that the device of Mueller meets the structural limitations of the claim, and is capable of cutting aortic tissue between a true lumen and a false lumen. The forceps of Mueller are sized so that they are capable of being inserted into a true lumen and a false lumen and contain a cutting blade therebetween for cutting tissue.
The language “to selectively grasp aortic tissue… to cut at least a portion of the aortic tissue while the pair of jaw members grasps the aortic tissue” constitutes functional claim language, indicating that the claimed device need only be capable of being used in such a manner. Furthermore, the claim is an apparatus claim, and is to be limited by structural limitations. The Office submits that the device of Mueller meets the structural limitations of the claim, and the device is capable of selectively grasping aortic tissue and cutting at least a portion of the aortic tissue while the pair of jaw members grasps the aortic tissue. The device of Mueller grasps tissue between the jaws and cuts that tissue, thus it would be capable of doing the same to aortic tissue.
Regarding claim 2 Mueller further discloses (fig. 1 and 5-9) the handle device (20+30) further comprises a cutter actuator 70 member operable to move the cutting mechanism 410 within the channel 482 in response to actuation of the cutter actuator member 70 (see [0059]).
Regarding claim 3 Mueller further discloses (fig. 1 and 5-9) the cutter actuator member 70 is configured to be coupled to a body portion 20 of the handle device (20+30) for fore-aft actuation to drive the cutting mechanism 410 within the channel 482 (see fig. 1, [0059]-[0060]).
Regarding claim 5 Mueller further discloses (fig. 1 and 5-9) the handle device (20+30) is configured to be grasped by a surgeon and the jaw actuator member 40 is configured to be pivotally coupled to a body portion 20 of the handle device for pivotal movement in opposing directions (see fig. 1 [0035], [0040] and [0048]-[0049].
Regarding claim 6 Mueller further discloses (fig. 1 and 5-9) the cutting mechanism 410 is configured to cut in a single direction (see fig. 8, only one side of the cutting blade is sharp.
Regarding claim 8 Mueller further discloses (fig. 1 and 5-9) at least one of the pair of jaw members (402, 404) is generally coaxial with a distal end of the sheath member 12 (see fig. 3B).
Regarding claim 11 Mueller further discloses (fig. 1 and 5-9) the distal head assembly 400 comprises a tissue stop member (see fig. annotated 8 below) selectively contacting aortic tissue and configured to align the cutting mechanism relative to uncut aortic tissue.
The language “a tissue stop member selectively contacting aortic tissue and configured to align the cutting mechanism relative to uncut aortic tissue” constitutes functional claim language, indicating that the claimed device need only be capable of being used in such a manner. Furthermore, the claim is an apparatus claim, and is to be limited by structural limitations. The Office submits that the device of Mueller meets the structural limitations of the claim, and the tissue stop member is capable of contacting aortic tissue and configured to align the cutting mechanism relative to uncut aortic tissue. The identified tissue stop member is positioned between the jaws where tissue is grasped, therefore it is capable of contacting tissue. Furthermore, tissue that contacts it would be prevented from moving reward which can align the cutting mechanism relative to uncut aortic tissue.
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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 4 is rejected under 35 U.S.C. 103 as being unpatentable over Mueller in view of Alsac et al. (US 20150148828 A1).
Regarding claim 4, Mueller discloses the claimed invention substantially as claimed, as set forth above for claim 1. Mueller is silent regarding a first guidewire configured to extend within the true lumen; a second guidewire configured to extend within the false lumen, a first guidewire slot formed in a first of the pair of jaw members and a second guidewire slot formed in a second of the pair of jaw members, the first guidewire extending through the first guidewire slot to guide movement of the first jaw member within the true lumen and the second guidewire extending through the second guidewire slot to guide movement of the second jaw member within the false lumen.
However Alsac, in the same filed of endeavor, teaches (fig. 1-3) a first guidewire 50 configured to extend within the true lumen 1; a second guidewire 50 configured to extend within the false lumen 2 (see fig. 1 and [0009]), a first guidewire slot 116 formed in a first 11 of the pair of jaw members (11, 12; see fig. 3 and [0055]) and a second guidewire slot 126 formed in a second 12 of the pair of jaw members (11, 12; see fig. 3 and [0055]), the first guidewire 50 extending through the first guidewire slot 116 to guide movement of the first jaw member 11 within the true lumen 1 (see [0037]-[0039] and [0057]) and the second guidewire 50 extending through the second guidewire slot 126 to guide movement of the second jaw member 12 within the false lumen (see [0037]-[0039] and [0057]).
Therefore it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify Mueller to have a first guidewire configured to extend within the true lumen; a second guidewire configured to extend within the false lumen, a first guidewire slot formed in a first of the pair of jaw members and a second guidewire slot formed in a second of the pair of jaw members, the first guidewire extending through the first guidewire slot to guide movement of the first jaw member within the true lumen and the second guidewire extending through the second guidewire slot to guide movement of the second jaw member within the false lumen as taught by Alsac, for the purpose of being able to guide each jaw member to a different location to position the desired tissue between them (see Alsac [0033]-[0039]).
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Mueller in view of Schulze et al. (US 5,797,941 A1).
Regarding claim 7, Mueller discloses the claimed invention substantially as claimed, as set forth above for claim 1. Mueller is silent regarding the cutting mechanism is configured to cut in at least two directions.
However Schulze, in the same filed of endeavor, teaches (fig. 1 and 3-5) a pair of jaws (16, 17) with a cutting mechanism 22 therebetween (see fig. 1 and col. 2 ln. 54 – col. 3 ln. 3), therein the cutting mechanism 22 is configured to cut in at least two directions (direction towards the distal end 16/17 and direction perpendicular to that which the cutting member expands in; see fig. 4-5 and col. 3 ln. 4-19).
Therefore it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify Mueller to have the cutting mechanism is configured to cut in at least two directions as taught by Schulze, for the purpose of being able to cut thicker tissue (see Schulze col. 3 ln. 4-19).
Claims 9-10 are rejected under 35 U.S.C. 103 as being unpatentable over Mueller in view of Bliss et al. (US 20110144672 A1).
Regarding claims 9-10, Mueller discloses the claimed invention substantially as claimed, as set forth above for claim 1. Mueller is silent regarding a flexible tip portion extending from at least one of the pair of jaw members; the flexible tip is tapered.
However Bliss, in the same filed of endeavor, teaches (fig. 16) a flexible (heat-shrinkable polymeric material is flexible) tip portion (heat-shrinkable polymeric material on 41, see [0121]) extending from at least one of the pair of jaw members 41 (see fig. 16); the flexible tip is tapered (see fig. 16).
Therefore it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify Mueller to have a flexible tip portion extending from at least one of the pair of jaw members; the flexible tip is tapered as taught by Bliss, for the purpose of having an atraumatic tip to prevent damage of the tissue while the device is navigated to the treatment location (see Bliss [0121]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KATHERINE H SCHWIKER whose telephone number is (571)272-9503. The examiner can normally be reached Monday - Friday 7:30 am-4:00 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Darwin Erezo can be reached at (571) 272-4695. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KATHERINE H SCHWIKER/Primary Examiner, Art Unit 3771
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