DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
2. 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.
Claim Objections
3. Applicant is advised that should claim 38 be found allowable, claim 39 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
Claim Rejections - 35 USC § 102
4. 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.
5. Claims 21, 24-28, 31-33, 35-36, and 40 rejected under 35 U.S.C. 102(a)(1) as being anticipated by McClurken U.S. 7,311,708 (herein referred to as “McClurken”).
6. Regarding Claim 21, McClurken teaches a tip electrode (Figs. 9-16) comprising:
a. an electrically-insulative substrate (Fig. 12, ref num 26; Col. 22, lines 4-6, “Probe body 26 may comprise a solid, electrically non-conductive, insulative material”) comprising a receiving lumen (Fig. 12, ref num 41), a plurality of irrigation flow holes (Fig. 9, ref num 44a, 44b), and a tip portion (Fig. 9, ref num 5a), an inner surface of the electrically-insulative substrate defining the receiving lumen (see Fig. 12, inner surface of ref num 26 defines ref num 41), the irrigation flow holes extending radially through the electrically-insulative substrate (see Fig. 12, ref nums 44a and 44b extend radially through ref num 26);
b. a plurality of equally spaced longitudinally extending segmented electrodes (Fig. 9, ref nums 29a-c and 30a-c) comprising a layer of conductive material deposited on an outer surface of the tip portion (Col. 24, lines 35-39, “Each conductor 29, 30 may be branched into, for example, additional sub-conductors, such as comprising three elongated longitudinally directed strip electrodes 29a, 29b, 29c and 30a, 30b, 30c which will provide energy to treat tissue”), the plurality of irrigation flow holes located between the plurality of equally spaced longitudinally extending segmented electrodes (see Fig. 9, ref nums 44a are between ref nums 29a-c and 30a-c); and
c. an insulation sleeve configured to circumferentially surround and electrically insulate a proximal portion of the tip electrode (see Fig. 12, ref num 26 contains insulative material at the proximal portion of ref num 5a).
7. Regarding Claim 24, McClurken teaches the insulation sleeve comprises at least one recess gap (Fig. 10, ref num 37).
8. Regarding Claim 25, McClurken teaches the electrically-insulative substrate electrically insulates at least two segmented tip electrodes of the plurality of segmented electrodes from one another (Fig. 11, ref num 28 is the exposed outer surface of ref num 26, which electrically insulates the electrodes 29a-c from one another).
9. Regarding Claim 26, McClurken teaches a fluid lumen alignment feature (Fig. 12, ref num 40) coupled to the inner surface of the electrically-insulative substrate (see Fig. 12), the fluid lumen alignment feature configured to couple with the insulation sleeve (Fig. 12, ref num 40 is coupled with the proximal end of ref num 5a which is insulated).
10. Regarding Claim 27, McClurken teaches a through channel extending from the inner surface of the electrically-insulative substrate to an outer surface of the electrically-insulative substrate (see Fig. 12, ref nums 43a and 43b).
11. Regarding Claim 28, McClurken teaches a conductor grooming component proximal to the electrically-insulative substrate and configured to secure a plurality of conductor wires (Fig. 10, ref num 34 secures ref nums 21a and 21b).
12. Regarding Claim 31, McClurken teaches a catheter assembly (Fig. 7) comprising:
a. a catheter shaft (Fig. 8, ref num 19);
b. a segmented tip electrode coupled to a distal portion of the catheter shaft (Figs. 8 and 9, ref num 5a), the segmented tip electrode comprising:
b.1 an electrically-insulative substrate (Fig. 12, ref num 26; Col. 22, lines 4-6, “Probe body 26 may comprise a solid, electrically non-conductive, insulative material”) comprising a receiving lumen (Fig. 12, ref num 41), a plurality of irrigation flow holes (Fig. 9, ref num 44a, 44b), an inner surface of the electrically-insulative substrate defining the receiving lumen (see Fig. 12, inner surface of ref num 26 defines ref num 41), the irrigation flow holes extending radially through the electrically-insulative substrate (see Fig. 12, ref nums 44a and 44b extend radially through ref num 26);
b.2 a plurality of equally spaced longitudinally extending segmented electrodes (Fig. 9, ref nums 30a-c) comprising a layer of conductive material deposited on an outer surface of the tip portion (Col. 24, lines 35-39, “Each conductor 29, 30 may be branched into, for example, additional sub-conductors, such as comprising three elongated longitudinally directed strip electrodes 29a, 29b, 29c and 30a, 30b, 30c which will provide energy to treat tissue”), the plurality of irrigation flow holes located between the plurality of equally spaced longitudinally extending segmented electrodes (see Fig. 9, ref nums 44a 30a-c); and
c. at least one ring electrode coupled to a proximal portion of the catheter shaft (Fig. 10, ref num 29).
13. Regarding Claim 32, McClurken teaches the at least one ring electrode comprises a segmented ring electrode (Fig. 10, ref num 29 has segments ref nums 29a-c).
14. Regarding Claim 33, McClurken teaches the segmented ring electrode comprises an inner electrode support (Fig. 10, ref num 34), a conductive material (understood that ref num 29 has conductive material), an outer support segment (Fig. 14, ref num 28), a polymeric skin (Col. 29, lines 54-67 – Col. 30, lines 1-3), a plurality of electrode segments (Fig. 10, ref num 29a-c), and a plurality of conductor wires (Fig. 10, ref num 21a and 21b).
15. Regarding Claim 35, McClurken teaches the conductive material (Fig. 14, ref num 36a-c) is deposited on an outer surface of the inner electrode support to form a plurality of printed receivers and the plurality of electrode segments are each electrically coupled to a separate printed receiver (Col. 25, lines 41-43, “The electrical coupling between electrodes 29a-c and conductor 29 is preferably made via radially displaced localized conductive tabs 36a-c”; Col. 25, lines 34-50).
16. Regarding Claim 36, McClurken teaches an insulation sleeve configured to circumferentially surround and electrically insulate a proximal portion of the tip electrode (see Fig. 12, ref num 26 contains insulative material at the proximal portion of ref num 5a).
17. Regarding Claim 40, McClurken teaches the insulation sleeve comprises at least one recess gap (Fig. 10, ref num 37).
Claim Rejections - 35 USC § 103
18. 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.
19. Claims 22-23 and 37-39 are rejected under 35 U.S.C. 103 as being unpatentable over McClurken and in view of Potter U.S. 8,226,641 (herein referred to as “Potter”).
20. Regarding Claim 22, McClurken fails to teach a deflection pull ring configured to mate with the insulation sleeve.
Potter teaches a tip electrode of analogous art (Fig. 2), wherein the tip electrode comprises a deflection pull ring (Fig. 2, ref num 25) configured to mate with an insulation sleeve (Fig. 2, ref num 20, 21; as shown in Fig. 2, ref num 25 mates with ref num 20, 21; Col. 3, lines 6-8, “A pull ring assembly includes a deflection pull ring 25 positioned around the shaft 21”; Col. 3, lines 44-56). This allows for the deflection of the distal end of the tip electrode in whatever direction is needed (Col. 3, lines 11-16). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified McClurken to include a deflection pull ring that mates with the insulation sleeve in order to provide flexibility to the distal tip electrode.
21. Regarding Claim 23, McClurken fails to teach the deflection pull ring comprises at least one clip lock configured to mate with a relief opening of the insulation sleeve.
Potter teaches the deflection pull ring (Fig. 2, ref num 25) comprises at least one clip lock (Fig. 2, ref num 40, 42) configured to mate with a relief opening of the insulation sleeve (Fig. 2, ref num 40 mates with ref num 42 mates with free end, ref num 37). This mounts the catheter to the tip electrode (Col. 3, lines 57-67). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified McClurken to have included a clip lock configured to mate with a relief opening of the insulation sleeve so that the deflection pull ring would be attached to the insulation ring.
22. Regarding Claim 37, McClurken fails to teach a deflection pull ring configured to mate with the insulation sleeve.
Potter teaches a tip electrode of analogous art (Fig. 2), wherein the tip electrode comprises a deflection pull ring (Fig. 2, ref num 25) configured to mate with an insulation sleeve (Fig. 2, ref num 20, 21; as shown in Fig. 2, ref num 25 mates with ref num 20, 21; Col. 3, lines 6-8, “A pull ring assembly includes a deflection pull ring 25 positioned around the shaft 21”; Col. 3, lines 44-56). This allows for the deflection of the distal end of the tip electrode in whatever direction is needed (Col. 3, lines 11-16). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified McClurken to include a deflection pull ring that mates with the insulation sleeve in order to provide flexibility to the distal tip electrode.
23. Regarding Claim 38, McClurken fails to teach the deflection pull ring comprises at least one clip lock configured to mate with a relief opening of the insulation sleeve.
Potter teaches the deflection pull ring (Fig. 2, ref num 25) comprises at least one clip lock (Fig. 2, ref num 40, 42) configured to mate with a relief opening of the insulation sleeve (Fig. 2, ref num 40 mates with ref num 42 mates with free end, ref num 37). This mounts the catheter to the tip electrode (Col. 3, lines 57-67). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified McClurken to have included a clip lock configured to mate with a relief opening of the insulation sleeve so that the deflection pull ring would be attached to the insulation ring.
24. Regarding Claim 39, McClurken fails to teach the deflection pull ring comprises at least one clip lock configured to mate with a relief opening of the insulation sleeve.
Potter teaches the deflection pull ring (Fig. 2, ref num 25) comprises at least one clip lock (Fig. 2, ref num 40, 42) configured to mate with a relief opening of the insulation sleeve (Fig. 2, ref num 40 mates with ref num 42 mates with free end, ref num 37). This mounts the catheter to the tip electrode (Col. 3, lines 57-67). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified McClurken to have included a clip lock configured to mate with a relief opening of the insulation sleeve so that the deflection pull ring would be attached to the insulation ring.
25. Claims 29-30 are rejected under 35 U.S.C. 103 as being unpatentable over McClurken and in view of Kim U.S. 8,414,579 (herein referred to as “Kim”).
26. Regarding Claim 29, McClurken fails to teach the conductor grooming component defines a central lumen, the insulation sleeve extending through the central lumen of the conductor grooming element.
Kim teaches a tip electrode of analogous art (Figs. 1A, 8A-8C, 10), wherein the tip electrode comprises a conductor grooming component (Fig. 8A, ref num 832A), such that the conductor grooming component defines a central lumen (see Fig. 8A, ref num 832A comprises a central lumen) that the insulation sleeve extends through (Fig. 8A, ref num 836 extends through central lumen of ref num 832A; also see configuration in Fig. 10). This aids in providing a seal between the insulation sleeve and exterior of the electrode tip (Col. 7, lines 25-32). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified McClurken to include a central lumen in the conductor grooming component in order to provide a seal between the electrode tip and the insulation sleeve.
27. Regarding Claim 30, McClurken teaches the plurality of conductor wires extend through a plurality of lumens connected to the central lumen of the conductor grooming component (see Fig. 10; Col. 21, lines 56-60, “the tube 19 may incorporate the conductors 38a, 38b of wires 21a, 21b in the tube wall (in essence creating a multi-lumen tube comprising three lumens where two of the lumens are occupied exclusively by the conductors 38a, 38b of wires 21a, 21b)…”).
28. Claim 34 is rejected under 35 U.S.C. 103 as being unpatentable over McClurken and in view of Barker U.S. 2011/0313500 (herein referred to as “Barker”).
29. Regarding Claim 34, McClurken teaches the outer support segment is configured to circumferentially surround the inner electrode support (see Fig. 12 and 14, ref num 28 surrounds ref num 34).
McClurken fails to teach the outer support segment comprises a plurality of notches configured to overlay each of the electrode segments.
Barker teaches a segmented ring electrode of analogous art (Figs. 1A, 6A), wherein the ring electrode comprises an outer support segment (Fig. 6A, ref num 610) that has a plurality of notches configured to overlay each of a plurality of electrode segments (Fig. 6A, ref num 610 contains notches 620 that overlay the electrodes (para 0071). This configuration allows for the electrodes to be coupled to the rest of the device (para 0071). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified McClurken to have a plurality of notches that overlay the electrode segments in order to couple the segmented ring electrode to the catheter assembly.
Conclusion
30. Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANNIE L SHOULDERS whose telephone number is (571)272-3846. The examiner can normally be reached Monday-Friday (alternate Fridays) 8AM-5PM EST.
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, Joseph Stoklosa can be reached at 571-272-1213. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/ANNIE L SHOULDERS/Examiner, Art Unit 3794
Prosecution Insights