DETAILED ACTION
A complete action on the merits of claims 1-15 follows below.
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 .
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 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.
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, 5-10 and 14 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 pre-AIA the applicant regards as the invention.
Claim 3 recites the limitation “the electrode support portion has an opening area that changes after the electrode portion is exposed”. It is noted that independent claim 1 already introduces the limitation “an opening area of the electrode support portion changes according to an extent to which a predetermined area of the electrode support portion is exposed”. It is therefore unclear if the two openings are the same or different. For analysis, they are interpreted to be the same, thus it is unclear how claim 3 further defines the catheter of claim 1. Clarification and appropriate correction is required.
Claim 5 recites the limitation “the electrode support portion includes a plurality of electrode support portions”. It is unclear how a previously claimed single electrode support portion can include a plurality of electrode support portions. If a plurality of distinct electrode support portions are being claimed, it is suggested to amend claim 1 to introduce “at least one electrode support portion” in order to further define it to be a plurality of electrode support portions in this claim. It is further unclear if all of the plurality of electrode support portions are positioned the same as the one introduced in claim 1 or not (e.g., an opening area of (each of the at least one) [the] electrode support portion(s) changes according to an extent to which a predetermined area of (each of the at least one) [the] electrode support portion(s) is exposed by pulling the first tube proximally). Clarification and appropriate correction is required.
Claim 6 recites the limitation “the first area of the first electrode support portion has a length equal to or different from at least one of the first area of the second electrode support portion and the first area of the third electrode support portion in a longitudinal direction”. First, although it is acknowledged that claim 4 introduces “the electrode support portion includes: a distally disposed first area; a second area …; a third area …” a first area associated with each of the first electrode support portion, the second electrode support portion or the third electrode support portion have not been introduced. It is unclear if each of the first, second and third electrode support portions have the same first, second and third area or not. Furthermore, it does not appear that this claim is further limiting/defining the catheter since examiner takes the position that two lengths are either equal to one another or different than one another with no other possibilities therefore with the claim reciting “the first area of the first electrode support portion has a length equal to or different from at least one of the first area of the second electrode support portion and the first area of the third electrode support portion in a longitudinal direction” the claim does not add any specific structural limitations.
Claim 7 recites the limitation “the electrode portion includes a plurality of electrode portions, wherein the plurality of electrodes includes: a first electrode disposed in the first area of the first electrode support portion; a second electrode disposed in the first area of the second electrode support portion; and a third electrode disposed in the first area of the third electrode support portion”. First, it is unclear how a previously claimed single electrode portion can include a plurality of electrode portions. It is unclear if each of the plurality of electrode portions are distinct from one another or the one electrode portion comprises multiple electrode portions. Furthermore, as noted above with respect to claim 6, although it is acknowledged that claim 4 introduces “the electrode support portion includes: a distally disposed first area; a second area …; a third area …” a first area associated with each of the first electrode support portion, the second electrode support portion or the third electrode support portion have not been introduced. It is unclear if each of the first, second and third electrode support portions have the same first, second and third area or not. Furthermore, there is insufficient antecedent basis for “the plurality of electrodes” limitation in the claim. Since no “plurality of electrodes” have been introduced prior to this recitation, it is unclear what plurality of electrodes are being referred to.
Claims 8-10 are rejected due to dependency over a rejected claim.
Claim 14 recites the limitation “wherein the marker is disposed along predetermined intervals”. It is at most unclear how a single marker can be disposed along predetermined intervals. Clarification and appropriate correction is required.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 3 and 6 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which they depend on, or for failing to include all the limitations of the claim upon which they depend.
Claim 3 recites the limitation “wherein the electrode support portion has an opening area that changes after the electrode portion is exposed”, it is noted that claim 1 introduces the limitation “an opening area of the electrode support portion changes according to an extent to which a predetermined area of the electrode support portion is exposed by pulling the first tube proximally” it is therefore unclear how claim 3 is further defining/limiting the claimed invention of claim 1.
Claim 6 recites the limitation “wherein the first area of the first electrode support portion has a length equal to or different from at least one of the first area of the second electrode support portion and the first area of the third electrode support portion in a longitudinal direction”. It is examiner’s position that two elements either have the same length or different length; therefore by claiming “the first area of the first electrode support portion has a length equal to or different from at least one of the first area of the second electrode support portion and the first area of the third electrode support portion in a longitudinal direction” it is unclear how it further defines or limits the claim on which it depends on.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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 1-12 and 15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Deem (US Pub. No. 2014/0336638).
Regarding Claim 1, Deem teaches a catheter 200 (Figs. 4-5), comprising:
a first tube 220; and an electrode support portion (each branch of the distal segment 232 holding an electrode 233 is here interpreted to be an electrode support portion, Fig. 4) disposed inside the first tube (“Distal segment 232 of the electrode element may be delivered to a treatment site in a closed or contracted configuration within probe 220” [0097]), wherein an opening area of the electrode support portion changes according to an extent to which a predetermined area of the electrode support portion is exposed by pulling the first tube proximally (“then opened or expanded to a treatment configuration at or near the treatment site. For example, the distal segment 232 can be expanded by advancing segment 232 out of probe 220 and/or by retracting the probe relative to the distal segment” [0097], as the electrode support member moves out of the probe 220 it opens or expands to the deployed configuration, the amount of its expansion/opening is related to the amount it is exposed here interpreted to be an opening area of the electrode support portion which changes according to an extent to which a predetermined area of the electrode support portion is exposed by pulling the first tube proximally, see [0097] and Fig. 5).
Regarding Claim 2, Deem teaches wherein the catheter comprises an electrode portion 233 disposed on the electrode support portion ([0097] and Fig. 5).
Regarding Claim 3, Deem teaches wherein the electrode support portion has an opening area that changes after the electrode portion is exposed (see the 112 rejection above as it is unclear how this limitation is different than that claimed in claim 1, as explained in the rejection of claim 1 “then opened or expanded to a treatment configuration at or near the treatment site. For example, the distal segment 232 can be expanded by advancing segment 232 out of probe 220 and/or by retracting the probe relative to the distal segment” [0097], as the electrode support member moves out of the probe 220 it opens or expands to the deployed configuration, the amount of its expansion/opening is related to the amount it is exposed here interpreted to be an opening area of the electrode support portion which changes according to an extent to which a predetermined area of the electrode support portion is exposed by pulling the first tube proximally, see [0097] and Fig. 5).
Regarding Claim 4, Deem teaches wherein the electrode support portion includes: a distally disposed first area (the distal tip area, see the annotated figure below); a second area in contact with a proximal end of the first area and extending proximally and inside of the first tube (depending on the amount of exposure the area interpreted to be the second area on the annotated figure below is configured to be positioned inside the probe 220); a third area in contact with a proximal end of the second area and extending proximally (see the annotated figure below).
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Regarding Claim 5, Deem teaches wherein the electrode support portion includes a plurality of electrode support portions (as best understood in view of the 112 rejection above, see Fig. 5 showing multiple electrode support portions), wherein the plurality of electrode support portions includes a first electrode support portion, a second electrode support portion, and a third electrode support portion spaced apart from each other (more than three electrode support portions shown in Fig. 5).
Regarding Claim 6, Deem teaches wherein the first area of the first electrode support portion has a length equal to or different from at least one of the first area of the second electrode support portion and the first area of the third electrode support portion in a longitudinal direction (as seen in Fig. 5, each of the electrode support portions (branches) include a distal end here interpreted to be the first area which has a length that is either equal to or different from at least one of another electrode support portions in a longitudinal direction, see the 112 rejection above as it is unclear how this claim further defines the claimed invention as it is taken that two elements would either have a length equal or different than one another).
Regarding Claim 7, Deem teaches wherein the electrode portion includes a plurality of electrode portions (as best understood in view of the 112 rejection above, see Fig. 5 showing multiple electrode support portions), wherein the plurality of electrodes includes: a first electrode disposed in the first area of the first electrode support portion; a second electrode disposed in the first area of the second electrode support portion; and a third electrode disposed in the first area of the third electrode support portion (as best understood in view of the 112 rejection above, Fig. 5 shows more than one electrode support branches, each carrying an electrode 233 at its distal end).
Regarding Claim 8, Deem teaches wherein the first electrode, the second electrode, and the third electrode are disposed to be spaced apart in a longitudinal direction (by interpreting “a longitudinal direction” to be along the renal artery (RA), Fig. 5 shows each of the electrodes spaced apart in the longitudinal direction).
Regarding Claim 9, Deem teaches wherein the first electrode, the second electrode, and the third electrode are disposed to be offset from each other in a plane intersecting a longitudinal direction (given the broadest reasonable interpretation “a longitudinal direction” is here interpreted to be a longitudinal direction of the probe 220 and the plane intersecting the longitudinal axis is here interpreted to be a plane perpendicular to the longitudinal axis of the probe thereby the electrodes are positioned to be offset from each other in the plane intersecting the longitudinal direction, see Fig. 5).
Regarding Claim 10, Deem teaches wherein the first electrode support portion, the second electrode support portion, and the third electrode support portion are disposed to have the same angle with respect to a center of the first tube (see Fig. 5).
Regarding Claim 11, Deem teaches wherein the catheter comprises a second tube disposed inside the first tube (as can be seen in Fig. 5, the electrode element 230 comprises a tube here interpreted to be a second tube disposed inside the first tube 220).
Regarding Claim 12, Deem teaches wherein the electrode support portion is disposed between the first tube and the second tube (“apparatus 200 comprises introducer probe 220 and electrode element 230 with a distal segment 232 that may be expandable. Probe 220 may, for example, comprise a standard, needle or trocar. Electrode element 230 is proximally coupled to generator 100 and is configured for advancement through probe 220” [0097] thereby since the electrode support portions holding the electrodes 233 are coupled to the electrode element 230 extending through the lumen of probe 220, each of the electrode support portions are disposed between the first tube 220 and the second tube 230, see Fig. 5).
Regarding Claim 15, Deem teaches wherein the opening area changes in the first area or the second area (the expansion of the electrode support members occurs in the second area as interpreted, see the annotated figure above).
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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
Claims 13 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Deem as applied above in view of Fischell (US Pub. No. 2014/0121644).
Regarding Claims 13 and 14, although Deem teaches “Based on the results of the monitored parameters, the system can determine the location of renal nerves and/or whether denervation has occurred. Detectors for monitoring of such physiological responses include, for example, Doppler elements, thermocouples, pressure sensors, and imaging modalities (e.g., fluoroscopy, intravascular ultrasound, etc.)” [0042], Deem does not specifically teach further comprises a marker disposed in the second area and wherein the marker is disposed along predetermined intervals.
In the same field of invention, Fischell teaches “Fluoroscopic visualization of the correct deployment of the guide tubes and injection needles are highly desirable. There are several ways that this goal could be accomplished. It is envisioned that the injection needles, guiding tubes and injection tubes could be formed from a radiopaque material such as tantalum or tungsten or coated, or marked with a radiopaque material such as gold or platinum so as to make them clearly visible using fluoroscopy. The preferred method however is to place radiopaque marker bands near the distal ends of each guide tube and include a radiopaque wire within the lumen of each injector tube” in [0053]. It would have been obvious to one having ordinary skill in the art prior to the effective filing date of the current invention to use radiopaque marker bands near the distal ends of each guide tube and include a radiopaque wire within the lumen of each injector tube in the invention of Deem in order to better aid in the correct deployment of the treatment instrument under fluoroscopic visualization as Fischell teaches thereby the marker band is interpreted to be disposed in the second area and as best understood in view of the 112 rejection, the marker would be disposed along predetermined intervals on the distal ends of each of the electrode support portions.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KHADIJEH A VAHDAT whose telephone number is (571)270-7631. The examiner can normally be reached M-F 9-6 EST.
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/KHADIJEH A VAHDAT/Primary Examiner, Art Unit 3794