DETAILED ACTION
This action is in response to preliminary amendments received on 2/23/2026. Claims 1-3, 14, 18-20 and 22 have been amended. A complete action on the merits of claims 1-22 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 1-22 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 pre-AIA the applicant regards as the invention.
Independent Claims 1, 14 and 20 recite the limitation “a proximal end adapted for a user”. It is at most unclear what is meant by a proximal end adapted for a user. For analysis, it is interpreted to have some sort of a handle adapted for a user to hold or control; however, clarification and appropriate correction is required.
Claim 18 recites the limitation “a plurality of distal tips that each includes a corresponding different preformed-shaped electrode, wherein each of the plurality of distal tips is connectable at the distal end”. It is at most unclear how the plurality of distal tips are related to the “distal end adapted for introduction in a patient” and “a flexible electrode located at the distal end” and how each of the plurality of distal tips is connectable at the distal end and if they are also coupled to the electrode or if the claim is further reciting a plurality of electrodes. Clarification and appropriate correction is required.
Claims 2-13, 15-19 and 21-22 are rejected due to dependency over a rejected claim.
Claim Rejections - 35 USC § 102/103
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.
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 1-2 and 4-21 are rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Azamian (US Pub. No. 2016/0128767) in view of Franke (US Pub. No. 2020/0188660).
Regarding Claim 1, Azamian teaches an apparatus for ablating tissue (Fig. 11), comprising:
a catheter 1105 having a proximal end adapted for a user (to be held/guided by a user) and a distal end adapted for introduction in a patient (the distal end shown in Fig. 11); and
a cured hydrogel located at the distal end, wherein the cured hydrogel forms at least a portion of a flexible electrode (electrode 1110 coated by hydrogel 1115, [0227]-[0228]; “[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.” In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985); therefore, although the curing process is not disclosed by Azamian for the hydrogel to be applied to the electrode, since the hydrogel is provided on the tip of the electrode as a coating, examiner takes the position that either the coating has been cured over the electrode or in alternative, in view of the teachings of Franke, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the current invention to coat the electrode by a curing process in order to create a flexible tip electrode, see [0968] of Franke; furthermore, Azamian teaches “suitable adhesion means (e.g., UV cured adhesives…)” in [0246] directed to adhering flange 9006 of the inflation manifold 9003).
Regarding Claim 2, Azamian teaches wherein the flexible electrode is retractable in a lumen provided at the distal end (by the use of a guide extension catheter such as 10120 shown in Fig. 102, the flexible electrode is retractable in a lumen of the guide catheter provided at the distal end).
Regarding Claim 4, Azamian teaches wherein the flexible electrode is coverable by a sheath provided at the distal end (by the use of a guide extension catheter such as 10120 shown in Fig. 102, the flexible electrode is coverable by a sheath (the guide catheter) provided at the distal end).
Regarding Claim 5, Azamian teaches wherein at least a portion of the cured hydrogel is conductive ([0228]).
Regarding Claim 6, Azamian teaches wherein the proximal end includes a connector electrically coupled to the flexible electrode and the connector is capable of being connected to an electric generator (similar to the embodiment of Fig. 104, the proximal end of the catheter is coupled to a generator 10405 to supply RF energy to electrode 1110, [0218]-[0219], [0254]).
Regarding Claim 7, Azamian teaches wherein the cured hydrogel is conductive ([0228]).
Regarding Claim 8, Azamian teaches wherein the flexible electrode is made by curing hydrogel around a tubular electrode located in a mold (by curing hydrogel 1115 around a tubular electrode 1110, Fig. 11).
Regarding Claim 9, Azamian teaches wherein the flexible electrode is made by curing hydrogel around a tubular solid electrode centrally located in a mold (by curing hydrogel 1115 around a tubular electrode 1110, Fig. 11).
Regarding Claim 10, Azamian teaches wherein the flexible electrode is configured to deliver bipolar RF ablation (“least one electrode may comprise one or more monopolar electrodes or one or more bipolar electrode pairs” [0047]).
Regarding Claim 11, Azamian teaches wherein the flexible electrode has a sponge-like texture, with an aerated network, or a combination of a continuous structure and a sponge-like structure (“the hydrogel coating 1115 on the ablation electrode 1110 may absorb water from the surrounding tissues” [0228] therefore, examiner takes the position that since the hydrogel coating is configured to absorb water, it must have a sponge-like texture and thus is a combination of a continuous structure and a sponge-like structure).
Regarding Claim 12, Azamian in view of Franke teaches wherein the flexible electrode is deformable (“advantage of curing the electrode inside the body is to adapt to any anatomy of interest and, for specific mixtures, retain the ability to deform mechanically” [0573] of Franke).
Regarding Claim 13, Azamian teaches further comprising a steering mechanism controllable with the proximal end (“the RF ablation catheter comprises an actuatable (e.g., steerable, articulatable, expandable) distal tip configured to maintain sufficient contact pressure of the at least one electrode against the inner wall of the hepatic artery branch” [0033], also see [0171] and [0174]).
Regarding Claim 14, Azamian teaches a system for ablating tissue, comprising:
a surgical instrument (Fig. 11) including: a catheter 1105 having a proximal end adapted for a user (to be held/guided by a user) and a distal end adapted for introduction in a patient (the distal end shown in Fig. 11); and
a flexible electrode located at the distal end, wherein the flexible electrode is formed from a cured hydrogel formed on a solid electrode (electrode 1110 coated by hydrogel 1115, [0227]-[0228]; “[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.” In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985); therefore, although the curing process is not disclosed by Azamian for the hydrogel to be applied to the electrode, since the hydrogel is provided on the tip of the electrode as a coating, examiner takes the position that either the coating has been cured over the electrode or in alternative, in view of the teachings of Franke, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the current invention to coat the electrode by a curing process in order to create a flexible tip electrode, see [0968] of Franke; furthermore, Azamian teaches “suitable adhesion means (e.g., UV cured adhesives…)” in [0246] directed to adhering flange 9006 of the inflation manifold 9003); and
an electric generator connected to the flexible electrode (similar to the embodiment of Fig. 104, the proximal end of the catheter is coupled to a generator 10405 to supply RF energy to electrode 1110, [0218]-[0219], [0254]).
Regarding Claim 15, Azamian teaches wherein at least a portion of the cured hydrogel is conductive ([0228]).
Regarding Claim 16, Azamian teaches wherein the cured hydrogel is conductive ([0228]).
Regarding Claim 17, Azamian in view of Franke teaches wherein the flexible electrode is deformable (“advantage of curing the electrode inside the body is to adapt to any anatomy of interest and, for specific mixtures, retain the ability to deform mechanically” [0573] of Franke).
Regarding Claim 18, Azamian teaches further comprising a plurality of distal tips that each includes a corresponding different preformed-shaped electrode, wherein each of the plurality of distal tips is connectable at the distal end (see the 112 rejection above as it is unclear how the plurality of distal tips claimed here is related to the instrument of claim 14! Azamian teaches the use of multiple electrodes, thus multiple tips in “a radiofrequency (RF) ablation catheter comprising one or more electrodes” [0027] and “The at least one electrode may comprise a plurality of electrodes configured to deliver thermal energy to multiple locations within the hepatic artery branch simultaneously or sequentially” [0048] such as in Fig. 3 [0135], Fig. 27A-B “If multiple electrodes or other treatment members are used, the multiple members may be spaced at various positions along the length and/or circumference of the expandable element, thereby facilitating treatment at multiple locations (simultaneously or separately)” [0104], Figs. 48A-B, Fig. 79 and Fig. 106).
Regarding Claim 19, Azamian teaches wherein each of the plurality of distal tips is retractible in a lumen provided at the distal end or coverable by a sheath provided at the distal end (by the use of a guide extension catheter such as 10120 shown in Fig. 102, the distal end and thus multiple distal tips are retractable in a lumen of the guide catheter provided at the distal end).
Regarding Claim 20, Azamian teaches a method of ablating tissue (“cardiac ablation procedures” [0376]), comprising:
providing an apparatus including: a catheter 1105 having a proximal end adapted for a user (to be held/guided by a user) and a distal end adapted for introduction in a patient (the distal end shown in Fig. 11); and
a flexible electrode 1115 located at the distal end, wherein the flexible electrode is formed from a [cured] hydrogel formed on a solid electrode 1110 (“hydrogel that swells when exposed to tissues” [0226] and “the hydrogel coating 1115 on the ablation electrode 1110 may absorb water from the surrounding tissues and blood” [0228]; thereby the electrode is flexible); introducing the catheter in a patient (Fig. 11); contacting a target tissue of the patient with the flexible electrode (similar to contacting the tissue with electrode 1420 in Fig. 14B); and ablating the target tissue ([0218]-[0223] and [0227]-[0228]);
Although Azamian teaches the flexible electrode is formed from a hydrogel formed on a solid electrode in Fig. 11 and [0227]-[0228] and “suitable adhesion means (e.g., UV cured adhesives…)” in [0246] directed to adhering flange 9006 of the inflation manifold 9003, does not teach the cured process to adhere the hydrogel coating to the electrode.
In the same field of invention, Franke teaches curing hydrogel from a liquid phase to mold and conform to a solid phase ([0179], [0182], [0187], [0670], [0711], [0823] and [0968]). It would have been obvious to one having ordinary skill in the art prior to the effective filing date of the current invention to coat the electrode by a curing process in order to create a flexible tip electrode configured to conform/mold to the surrounding area such as the solid electrode 1110 of Azamian in Fig. 11.
Regarding Claim 21, Azamian teaches wherein the target tissue is cardiac tissue (“cardiac ablation procedures” [0376]).
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Azamian in view of Franke as applied above and further in view of Tu (US Patent No. 6,231,570).
Regarding Claim 3, Azamian teaches advancing the catheter and thereby the distal tip/electrode to the target area through a guide catheter; however, does not specifically teach wherein the flexible electrode is retractable using a plunger mechanism connected to the proximal end.
In the same field of ablation catheter invention, Tu teaches retracting and advancing a distal tip out of a catheter with a “push-pull plunger of the push-pull mechanism which is quantifiable and controllable” Col. 3, ll. 36-38.
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 a similar push/pull plunger in order to better control the retraction/advancement of the distal tip out of the guide catheter of Azamian as a plunger mechanism is a known advance/retraction mechanism used in the art.
Claim 22 is rejected under 35 U.S.C. 103 as being unpatentable over Azamian in view of Franke as applied above and further in view of Harlev (US Pub. No. 2020/0205890).
Regarding Claim 22, Azamian teaches cardiac ablation procedures; however, does not specifically teach wherein the target tissue is a genesis of errant and abnormal heartbeats.
In the same field of invention, Harlev teaches the use of a flexible electrode for cardiac ablation to treat arrhythmia (abnormal heartbeat) [0087], [0135] and [0149].
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 the instrument of Azamian in cardiac ablation to treat arrhythmia since it is known in the art to use a flexible electrode for such cardiac ablation in order to create better lesions in view of the teachings of Harlev.
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.
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, Joanne Rodden can be reached at (303) 297-4276. 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.
/KHADIJEH A VAHDAT/Primary Examiner, Art Unit 3794
Prosecution Insights