DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application is being examined under the pre-AIA first to invent provisions.
Status of Claims
2. Claims 1-20 as originally filed on 11/22/2023 are pending, and have been examined on the merits.
Specification
3. The disclosure is objected to because of the following informalities:
¶[0001] of the as-filed Specification, at pg. 1, titled “CROSS-REFERENCE TO RELATED APPLICATION” should be amended to include the Patent Number (U.S. 11,857,250) of the Parent Application (U.S. 16/983,425).
Appropriate correction is required.
Claim Objections
4. Claims 2, 4, 12, 14, & 18 are objected to because of the following informalities:
a. In claim 2, line 2, the recitation of “the thermocouple being configured to” should instead recite --the at least one thermocouple being configured to--.
b. In claim 4, line 2, the period (“.”) after “electrodes” should be deleted to correct the apparent typographical error.
c. In claim 4, line 2, the recitation of “in at least one selected from the group” should instead recite --in at least one energy delivery mode selected from the group--.
d. In claim 12, line 2, the recitation of “the thermocouple being configured to” should instead recite --the at least one thermocouple being configured to--.
e. In claim 14, line 2, the recitation of “in at least one selected from the group” should instead recite --in at least one energy delivery mode selected from the group--.
f. In claim 18, lines 3-4, the recitation of “in at least one selected from the group” should instead recite --in at least one energy delivery mode selected from the group--.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
5. 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.
6. Claims 5, 13-17, & 19 are rejected under 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 applicant regards as the invention.
7. Claim 5 recites the limitation “a first electrode and a second electrode of the plurality of electrodes is monitored to limit energy delivery to each electrode” in lines 2-3. This recitation renders the claim indefinite, as it is not clear whether the recitation of “each electrode” is referring to each electrode of the plurality of electrodes, or just each of the first and second electrodes. Clarification is required.
8. Claim 13 recites the limitation “an RF signal generator” in line 1. This recitation renders the claim indefinite, as it is not clear whether the recited “an RF signal generator” is intended to be the same RF signal generator previously recited in independent claim 11 (from which claim 13 depends), or a separate/additional RF signal generator. As such, the structure required by the claim is not clear, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Clarification is required.
9. Claims 14-17 are rejected as ultimately depending from a claim (claim 13) rejected under 35 U.S.C. 112, ¶2.
10. Claim 15 recites the limitation “a first electrode and a second electrode of the plurality of electrodes is monitored to limit energy delivery to each electrode” in lines 2-3. This recitation renders the claim indefinite, as it is not clear whether the recitation of “each electrode” is referring to each electrode of the plurality of electrodes, or just each of the first and second electrodes. Clarification is required.
11. Claim 19 recites the limitation “monitoring a first electrode and a second electrode of the plurality of electrodes to limit energy delivery to each electrode” in lines 2-3. This recitation renders the claim indefinite, as it is not clear whether the recitation of “each electrode” is referring to each electrode of the plurality of electrodes, or just each of the first and second electrodes. Clarification is required.
Claim Rejections - 35 USC § 102
12. The following is a quotation of the appropriate paragraphs of pre-AIA 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 –
(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States.
13. Claims 18-20 are rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by U.S. Patent Application Publication No. 2008/0281312 to Werneth et al. (“Werneth”) [made of record in Applicant’s 11/22/23 IDS].
14. Regarding claim 18, Werneth discloses a method for delivering ablation energy [e.g., Abstract, ¶’s [0056], [0073]], the method comprising:
delivering, via an RF signal generator [RF Ablation Generator (16) - ¶[0056]; FIG. 1], RF energy to selected ones of a plurality of electrodes [plurality of electrodes (28) of electrode array (24) - ¶’s [0056], [0075], [0076]; FIGS. 8-10] arranged on a carrier arm [flexible carrier arm (35) - ¶[0075]; FIGS. 8-10] of a medical device [Pulmonary Vein Ablation Catheter (“PVAC”) (20) - ¶[0056]; FIGS. 1, 2, 5A-5D, & 8-10], the RF energy being delivered in at least one selected from the group consisting of monopolar, bipolar, and combination monopolar-bipolar energy delivery modes [e.g., ¶[0028] (“The generator is adapted to deliver energy in a bipolar mode, a monopolar mode, or the generator can deliver energy in a mode which combines bipolar and monopolar delivery”); see also ¶’s [0117], [0118], [0151]],
delivering, with the selected ones of the plurality of electrodes [(28)], ablation energy to a pulmonary vein [e.g., ¶[0056]] in response to receiving the RF energy [e.g., ¶[0197] (“Briefly, the RF Ablation Generator unit 16 functions to generate the ablative RF energy, as supplied to selected catheter electrodes or between selected pairs of electrodes for each respective electrode array, necessary to ablate cardiac tissue”)] ,
wherein the carrier arm [(35)] is transitionable between a linear configuration [stored or delivery configuration - ¶[0072]; FIG. 8] and an arcuate configuration [deployed or expanded configuration - ¶[0072]; FIG. 10].
15. Regarding claim 19, Werneth discloses all of the limitations of claim 18 for the reasons set forth in detail (above) in the Office Action.
Werneth further discloses:
during bipolar energy delivery, setting a target temperature [¶’s [0118], [0126], [0204], and
monitoring a first electrode and a second electrode of the plurality of electrodes to limit energy delivery to each electrode based upon the measurement of the temperature for each electrode relative to the target temperature [¶’s [0118], [0126], [0204].
16. Regarding claim 20, Werneth discloses all of the limitations of claim 18 for the reasons set forth in detail (above) in the Office Action.
Werneth further discloses:
during monopolar energy delivery, delivering, with the RF signal generator, the RF energy to each of the plurality of electrodes based upon a temperature measured by at least one thermocouple of the medical device [e.g., ¶’s [0029], [0076], [0119], [0204]].
Claim Rejections - 35 USC § 103
17. The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
18. The factual inquiries for establishing a background for determining obviousness under pre-AIA 35 U.S.C. 103(a) 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 1-17 stand rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Werneth in view of U.S. Patent Application Publication No. 2007/0083194 to Kunis et al. (“Kunis”) [made of record in Applicant’s 11/22/23 IDS].
20. Regarding claim 1, Werneth teaches a medical device [Pulmonary Vein Ablation Catheter (“PVAC”) (20) - ¶[0056]; FIGS. 1, 2, 5A-5D, & 8-10] comprising:
an elongate catheter body having a proximal portion, a distal portion, and a longitudinal axis [flexible outer catheter tube (31) - ¶[0074]; FIGS. 8-10];
a distal assembly [carrier assembly (33) - ¶[0075]; FIGS. 8-10] defined by the distal portion of the elongate catheter body [¶[0075]], the distal assembly [(33)] including a flexible carrier arm [flexible carrier arm (35) - ¶[0075]; FIGS. 8-10] coupled to the elongate catheter body [¶[0075]], the carrier arm [(35)]… having a plurality of electrodes [plurality of electrodes (28) of electrode array (24) - ¶’s [0056], [0075], [0076]; FIGS. 8-10] and being transitionable between a linear configuration [stored or delivery configuration - ¶[0072]; FIG. 8] and an arcuate configuration [deployed or expanded configuration - ¶[0072]; FIG. 10],
wherein the plurality of electrodes [(28)] is configured to deliver ablation energy to a pulmonary vein [e.g., ¶[0056]].
Carrier Arm Defining an Aperture
Werneth does not, however, teach:
the carrier arm defining an aperture.
Kunis, in a similar field of endeavor, teaches that it was known to route wires (conductors) through a lumen of a carrier arm and out a side hole formed therein to connect to electrodes mounted on the carrier arm [see, e.g., ¶0106] (“Wires, not shown, attach to plug 198 and travel through handle 195, through outer shaft 182 and attach to electrodes 188 and any other sensors or transducers integral to electrodes 188 or attached to carrier arm 186. The wires may be located on the external surface of carrier arm 186, or travel within a lumen of carrier arm 186, exiting through a side hole to attach to electrodes 188”)].
It would have been obvious to one having ordinary skill in the art, at the time the invention was made, to modify Werneth such that the carrier arm define apertures [side holes] therein for routing wires (conductors) there-through for connection to respective electrodes mounted on the carrier arm, as taught by Kunis, since such a known, art-recognized wire-routing configuration would provide the benefit/advantage of mitigating (if not eliminating) unintended damage to the wires (conductors) that may occur if they were otherwise mounted externally (to the carrier arm) and, e.g., became disconnected/damaged to inadvertent contact with anatomy (or possibly another portion of the catheter) during insertion/withdrawal.
21. Regarding claim 2, the combination of Werneth and Kunis teaches all of the limitations of claim 1 for the reasons set forth in detail (above) in the Office Action.
Werneth further teaches wherein the distal assembly [(33)] further includes at least one thermocouple, the thermocouple being configured to provide temperature feedback [e.g., ¶’s [0029], [0076], [0119], [0204]].
22. Regarding claim 3, the combination of Werneth and Kunis teaches all of the limitations of claim 2 for the reasons set forth in detail (above) in the Office Action.
Werneth further teaches:
an RF signal generator [RF Ablation Generator (16) - ¶[0056]; FIG. 1], the RF signal generator being configured to generate and control the delivery of RF energy based upon the temperature feedback from the at least one thermocouple [e.g., ¶’s [0029], [0076], [0119], [0204]].
23. Regarding claim 4, the combination of Werneth and Kunis teaches all of the limitations of claim 3 for the reasons set forth in detail (above) in the Office Action.
Werneth further teaches:
wherein the RF signal generator delivers RF energy to the plurality of electrodes[[.]] in at least one selected from the group consisting of monopolar, bipolar, and combination monopolar-bipolar energy delivery modes [e.g., ¶[0028] (“The generator is adapted to deliver energy in a bipolar mode, a monopolar mode, or the generator can deliver energy in a mode which combines bipolar and monopolar delivery”); see also ¶’s [0117], [0118], [0151]].
24. Regarding claim 5, the combination of Werneth and Kunis teaches all of the limitations of claim 4 for the reasons set forth in detail (above) in the Office Action.
Werneth further teaches wherein during bipolar energy delivery, a target temperature is set [e.g., ¶’s [0118], [0126], [0204]], and a first electrode and a second electrode of the plurality of electrodes is monitored to limit energy delivery to each electrode based upon the measurement of the temperature for each electrode relative to the target temperature [e.g., ¶’s [0118], [0126], [0204]].
25. Regarding claim 6, the combination of Werneth and Kunis teaches all of the limitations of claim 4 for the reasons set forth in detail (above) in the Office Action.
Werneth further teaches wherein during monopolar energy delivery the RF signal generator delivers RF energy to each of the plurality of electrodes based upon a temperature measured by the at least one thermocouple [e.g., ¶’s [0029], [0076], [0119], [0204]].
26. Regarding claim 7, the combination of Werneth and Kunis teaches all of the limitations of claim 4 for the reasons set forth in detail (above) in the Office Action.
Werneth further teaches wherein the monopolar, bipolar, or combination monopolar-bipolar energy delivery modes are delivered simultaneously or sequentially [e.g., ¶[0119] (“The energy delivery unit is configured to delivery RF energy in monopolar, bipolar or combination monopolar-bipolar energy delivery modes, simultaneously or sequentially, with or without "off" or no energy delivered time durations”)].
27. Regarding claim 8, the combination of Werneth and Kunis teaches all of the limitations of claim 4 for the reasons set forth in detail (above) in the Office Action.
Werneth further teaches wherein the monopolar, bipolar, or combination monopolar-bipolar energy delivery modes are delivered with durations of terminated energy delivery or without durations of terminated energy delivery [e.g., ¶[0119] (“The energy delivery unit is configured to delivery RF energy in monopolar, bipolar or combination monopolar-bipolar energy delivery modes, simultaneously or sequentially, with or without "off" or no energy delivered time durations”)].
28. Regarding claim 9, the combination of Werneth and Kunis teaches all of the limitations of claim 1 for the reasons set forth in detail (above) in the Office Action.
Werneth further teaches wherein the ablation energy is passed through the plurality of electrodes on the distal assembly at between 5-10 Watts [e.g., ¶’s [0117], [0121]].
29. Regarding claim 10, the combination of Werneth and Kunis teaches all of the limitations of claim 1 for the reasons set forth in detail (above) in the Office Action.
Werneth further teaches wherein, in the arcuate configuration, the plurality of electrodes are coplanar in a plane that is substantially orthogonal to the longitudinal axis of the elongate catheter body [e.g., ¶[0075]; FIG. 10].
30. Regarding claim 11, Werneth teaches a medical system comprising:
a medical device [Pulmonary Vein Ablation Catheter (“PVAC”) (20) - ¶[0056]; FIGS. 1, 2, 5A-5D, & 8-10] including[:]
an elongate catheter body having a proximal portion, a distal portion, and a longitudinal axis [flexible outer catheter tube (31) - ¶[0074]; FIGS. 8-10],
a distal assembly [carrier assembly (33) - ¶[0075]; FIGS. 8-10] defined by the distal portion of the elongate catheter body [¶[0075]], the distal assembly [(33)] including a flexible carrier arm [flexible carrier arm (35) - ¶[0075]; FIGS. 8-10] coupled to the elongate catheter body [¶[0075]],… and having a plurality of electrodes [plurality of electrodes (28) of electrode array (24) - ¶’s [0056], [0075], [0076]; FIGS. 8-10] and transitionable between a linear configuration [stored or delivery configuration - ¶[0072]; FIG. 8] and an arcuate configuration [deployed or expanded configuration - ¶[0072]; FIG. 10]; and
an RF signal generator [RF Ablation Generator (16) - ¶[0056]; FIG. 1] configured to deliver RF energy to selected ones of the plurality of electrodes [e.g., ¶[0197] (“Briefly, the RF Ablation Generator unit 16 functions to generate the ablative RF energy, as supplied to selected catheter electrodes or between selected pairs of electrodes for each respective electrode array, necessary to ablate cardiac tissue”)],
wherein the plurality of electrodes [(28)] are configured to deliver ablation energy to a pulmonary vein in response to receiving RF energy [e.g., ¶[0056]].
Carrier Arm Defining an Aperture
Werneth does not, however, teach:
the carrier arm defining an aperture.
Kunis, in a similar field of endeavor, teaches that it was known to route wires (conductors) through a lumen of a carrier arm and out a side hole formed therein to connect to electrodes mounted on the carrier arm [see, e.g., ¶0106] (“Wires, not shown, attach to plug 198 and travel through handle 195, through outer shaft 182 and attach to electrodes 188 and any other sensors or transducers integral to electrodes 188 or attached to carrier arm 186. The wires may be located on the external surface of carrier arm 186, or travel within a lumen of carrier arm 186, exiting through a side hole to attach to electrodes 188”)].
It would have been obvious to one having ordinary skill in the art, at the time the invention was made, to modify Werneth such that the carrier arm define apertures [side holes] therein for routing wires (conductors) there-through for connection to respective electrodes mounted on the carrier arm, as taught by Kunis, since such a known, art-recognized wire-routing configuration would provide the benefit/advantage of mitigating (if not eliminating) unintended damage to the wires (conductors) that may occur if they were otherwise mounted externally (to the carrier arm) and, e.g., became disconnected/damaged to inadvertent contact with anatomy (or possibly another portion of the catheter) during insertion/withdrawal.
31. Regarding claim 12, the combination of Werneth and Kunis teaches all of the limitations of claim 11 for the reasons set forth in detail (above) in the Office Action.
Werneth further teaches wherein the distal assembly [(33)] further includes at least one thermocouple, the thermocouple being configured to provide temperature feedback [e.g., ¶’s [0029], [0076], [0119], [0204]].
32. Regarding claim 13, the combination of Werneth and Kunis teaches all of the limitations of claim 12 for the reasons set forth in detail (above) in the Office Action.
Werneth further teaches:
an RF signal generator RF Ablation Generator (16) - ¶[0056]; FIG. 1], the RF signal generator being configured to generate and control the delivery of RF energy based upon the temperature feedback from the at least one thermocouple [e.g., ¶’s [0029], [0076], [0119], [0204]].
33. Regarding claim 14, the combination of Werneth and Kunis teaches all of the limitations of claim 13 for the reasons set forth in detail (above) in the Office Action.
Werneth further teaches wherein the RF signal generator delivers RF energy to the plurality of electrodes in at least one selected from the group consisting of monopolar, bipolar, and combination monopolar-bipolar energy delivery modes [e.g., ¶[0028] (“The generator is adapted to deliver energy in a bipolar mode, a monopolar mode, or the generator can deliver energy in a mode which combines bipolar and monopolar delivery”); see also ¶’s [0117], [0118], [0151]].
34. Regarding claim 15, the combination of Werneth and Kunis teaches all of the limitations of claim 14 for the reasons set forth in detail (above) in the Office Action.
Werneth further teaches wherein during bipolar energy delivery, a target temperature is set [e.g., ¶’s [0118], [0126], [0204]], and a first electrode and a second electrode of the plurality of electrodes is monitored to limit energy delivery to each electrode based upon the measurement of the temperature for each electrode relative to the target temperature [e.g., ¶’s [0118], [0126], [0204]].
35. Regarding claim 16, the combination of Werneth and Kunis teaches all of the limitations of claim 14 for the reasons set forth in detail (above) in the Office Action.
Werneth further teaches wherein during monopolar energy delivery the RF signal generator delivers RF energy to each of the plurality of electrodes based upon a temperature measured by the at least one thermocouple [e.g., ¶’s [0029], [0076], [0119], [0204]].
36. Regarding claim 17, the combination of Werneth and Kunis teaches all of the limitations of claim 14 for the reasons set forth in detail (above) in the Office Action.
Werneth further teaches wherein the monopolar, bipolar, or combination monopolar-bipolar energy delivery modes are delivered simultaneously or sequentially [e.g., ¶[0119] (“The energy delivery unit is configured to delivery RF energy in monopolar, bipolar or combination monopolar-bipolar energy delivery modes, simultaneously or sequentially, with or without "off" or no energy delivered time durations”)].
Double Patenting
37. The non-statutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321I or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP §§ 706.02(l)(1) – 706.02(l)(3) for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
38. Claims 1 & 11 are rejected on the ground of non-statutory double patenting as being unpatentable over claims 1, 2, 5, 10, 13, & 16 of U.S. Patent No. 10,765,476, issued September 8, 2020 (“the ‘476 Patent”).
39. Although the claims at issue are not identical, they are not patentably distinct from each other because the features of each of claims of the instant application listed below are found in some form in the highlighted claims of the ‘’476 Patent. While the subject matter may differ in language or slightly in scope, each of the instant claims listed below are not considered distinct from the associated claim(s) of the ‘476 Patent. At least the following relationships are noted by the Examiner:
Instant claim 1 to claims 1, 2, & 5 of the ‘476 Patent; &
Instant claim 11 to claims 10, 13, & 16 of the ‘476 Patent.
40. Claims 1-10 are rejected on the ground of non-statutory double patenting as being unpatentable over claims 1, & 5-12 of U.S. Patent No. 11,857,250, issued January 2, 2024 (“the ‘250 Patent”).
41. Although the claims at issue are not identical, they are not patentably distinct from each other because the features of each of claims of the instant application listed below are found in some form in the highlighted claims of the ‘’250 Patent. While the subject matter may differ in language or slightly in scope, each of the instant claims listed below are not considered distinct from the associated claim(s) of the ‘250 Patent. At least the following relationships are noted by the Examiner:
Instant claim 1 to claim 1 of the ‘250 Patent;
Instant claim 2 to claim 5 of the ‘250 Patent;
Instant claim 3 to claim 6 of the ‘250 Patent;
Instant claim 4 to claim 7 of the ‘250 Patent;
Instant claim 5 to claim 8 of the ‘250 Patent;
Instant claim 6 to claim 9 of the ‘250 Patent;
Instant claim 7 to claim 10 of the ‘250 Patent;
Instant claim 8 to claim 11 of the ‘250 Patent;
Instant claim 9 to claim 12 of the ‘250 Patent; &
Instant claim 10 to claim 1 of the ‘250 Patent.
Conclusion
42. Any inquiry concerning this communication or earlier communications from the examiner should be directed to Bradford C. Blaise whose telephone number is (571)272-5617. The examiner can normally be reached on Monday - Friday 8 AM-5 PM.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Linda Dvorak can be reached on 571-272-4764. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Bradford C. Blaise/Examiner, Art Unit 3794