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 1-15 and 18-22 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 1 and 22: Claim 1 is indefinite in light of the drawings. Claim 1 recites a scaffold in line 2 and then in lines 8-9 the claim recites “wherein the stent further comprises a second set of one or more electrodes electrically coupled to the pulse generator, said second set of electrodes being unconnected to the scaffold”. In the figures the only electrode which is not attached to the scaffold is the electrode which is found on the pulse generator. This is seen in figure 3B with electrode 156 placed on the pulse generator. In figure 4 electrodes 256 are attached to the scaffold. Nowhere in the drawings are there electrodes which are part of the stent which are also unattached to the scaffold. The stent, for the purpose of examination, is considered to include the scaffold and the stent electrodes. There is an electrode on the pulse generator, however the pulse generator is also connected to the scaffold and thus, under broadest reasonable interpretation, the electrode on the pulse generator can also be considered to be attached to the scaffold via the pulse generator. Therefore this language is considered indefinite. Similar language is found in claim 22 and therefore claim 22 is also rejected.
Claim 2 recites “wherein the first or second set of one or more electrodes are configured such that they extend distally of the distal end of the scaffold”. This language is indefinite in light of the drawings. Although the electrode on the pulse generator extends distally from the distal end of the scaffold, the electrodes (i.e. first set) are operably attached to the scaffold and are not extending distally of the distal end of the scaffold. In figures 4A and 4B electrodes 256 are at the distal most end but they do not extend distally.
Claim 4 recites “wherein the one or more electrodes are mounted to the pulse generator”. Claim 4 depends from claim 1 which recites a first set of one or more electrodes and a second set of one or more electrodes. It is unclear based on the claim language which electrodes are mounted on the pulse generator.
Claim 14 recites “the one or more electrodes mounted to the pulse generator”. Claim 14 depends from claim 1 which recites that the electrodes are connected to the pulse generator however they are not mounted, therefore claim 14 is indefinite.
The remainder of the claims are also rejected in that they depend from previously rejected claim 1.
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 –
Claims 1-2 and 18-21 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Tockman et al. US 2012/0022617.
Regarding claim 1: Tockman discloses a scaffold 90 (figures 3A-3B) which extends longitudinally and has an outer parameter which contacts a vessel wall 72 (figures 3A and 3B, paragraph 0049); a pulse generator 26 (figure 1, paragraph 0042) which is configured to generate electrical signals to deliver to a nerve (“neural stimulation”, paragraph 0043); the scaffold includes electrodes 60 (figures 3A and 3B) mounted to the wall of the stent (paragraph 0056) and are orientated to stimulate the vagus nerve 6 (figures 3A and 3B), conductors attach the electrodes which are individually programmable to the pulse generator (paragraphs 0046, 0057); the device of Tockman further includes additional electrodes 60 on the lead 22 (figures 3A/3B) which are not connected to the scaffold. The electrodes are aligned to stimulate the vagus nerve 6 (figures 3A and 3B) and are in contact to signal the wall of the vagus nerve (paragraphs 0056-57).
Regarding claim 2: Tockman discloses electrodes that extend distally to the stent 90 (figures 3A and 3B).
Regarding claims 18-20: Tockman discloses that the electrodes can assume a positive or negative polarity (paragraph 0046). In the design by Tockman the IMD sets the polarity for the electrodes and therefore they can be positive or negative, return or stimulating electrodes.
Regarding claim 21: Tockman discloses a substantially tubular stent (3A and 3B) which biases the stent against the walls of the carotid artery.
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.
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 3 is rejected under 35 U.S.C. 103 as being unpatentable over Tockman et al. US 2012/0022617 in view of Christopherson US 2012/0089153.
Regarding claim 3: Tockman discloses the claimed invention however Tockman does not disclose electrodes on the pulse generator. Christopherson however teaches of electrodes on the IPG case (paragraph 0050) as well as a stent device with electrodes (paragraph 0031). It therefore would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify Tockman to include electrodes on the IPG case, as taught by Christopherson, in order to compute impedance (Christopherson paragraph 0050).
Claims 5 and 22 are rejected under 35 U.S.C. 103 as being unpatentable over Tockman et al. US 2012/0022617 in view of Dagan et al US 2018/0092763.
Regarding claim 5: Tockman discloses the claimed invention however Tockman does not disclose that the pulse generator is attached to an inner surface of the stent. Dagan, figure 2A, however teaches of a control capsule 30 which is attached to the inner surface of the stent. It therefore would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify Tockman to include the pulse generator attached to an inner surface of the stent, as taught by Dagan, in order to facilitate coupling (paragraph 0109).
Regarding claim 22: Tockman discloses a pulse generator 26 (figure 1, paragraph 0042), a scaffold 90 (figures 3A and 3B) and distal electrodes coupled to the pulse generator 60 (figures 3A and 3B), in the design of Tockman some of the electrodes are on lead 22 and are distal to the scaffold. However, Tockman does not disclose the use of a deployment catheter. Dagan however teaches of a similar device in which a catheter is used for percutaneous placement of the stent in the aortic blood vessel the catheter is withdrawn once the system is in place (paragraph 0106). The stent 20 of Dagan includes coupling elements 31 which can also be used to remove and/or withdraw the stent (paragraph 0107). It therefore would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify Tockman to include a deployment catheter, as taught by Dagan, in order to place and potentially remove the stent.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Tockman et al. US 2012/0022617 in view of Kieval et al. US 8,583,236.
Regarding claim 6: Tockman discloses the claimed invention however Tockman does not disclose that the pulse generator is attached to an outer surface of the stent. Kieval however teaches of a stent like electrode structure 640 which has an electrode circuit attached to an outer surface of the stent like device (figure 19, column 19, lines 45-50). It therefore would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify Tockman to include electronics attached to the outer surface of the stent, as taught by Kieval, in order to utilize a flex circuit for compatibility.
Allowable Subject Matter
Claims 4, 12-13, 7-11 and 14-15 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
As allowable subject matter has been indicated, applicant's reply must either comply with all formal requirements or specifically traverse each requirement not complied with. See 37 CFR 1.111(b) and MPEP § 707.07(a).
The following is a statement of reasons for the indication of allowable subject matter. Multiple claims are potentially allowable, upon allowance and a detailed reasons for allowance will be provided. With respect to claims 4 and 14, electrodes mounted to the pulse generator and extending from a distal end of the scaffold appears to be a unique concept. The conductive cap of claim 12 appears to be a unique concept. The platforms of claim 7 appear to be a unique concept.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PAULA J. STICE whose telephone number is (303)297-4352. The examiner can normally be reached Monday - Friday 7:30am -4pm MST.
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PAULA J. STICE
Primary Examiner
Art Unit 3796
/PAULA J STICE/Primary Examiner, Art Unit 3796